Professional Documents
Culture Documents
Category/
SOP No.
1.
SPD/01
2.
SPD/02
3.
SPD/03
4.
SPD/04
5.
SPD/05
6.
SPD/06
7.
SPD/07
8.
SPD/08
9.
SPD/09
10.
SPD/10
11.
SPD/11
12.
SPD/12
13.
SPD/13
14.
SPD/14
15.
SPD/15
16.
SPD/16
17.
18.
SPD/17
SPD/18
19.
SPD/19
20.
SPD/20
21.
SPD/21
22.
SPD/22
23.
SPD/23
24.
SPD/24
25.
SPD/25
26.
SPD/26
Rmk
SPD/27
28.
SOP FOR LEAK TEST FOR CAPSULES/ TABLETS (STRIP AND BLISTER
PACKING)
SPD/28
29.
SPD/29
30.
SPD/30
31.
SPD/31
32.
SPD/32
33.
SPD/33
34.
SPD/34
35.
SPD/35
36.
37.
38
SPD/36
SPD/37
SPD/38
39.
SPD/39
40.
SPD/40
41.
SPD/41
42.
SPD/42
43.
SPD/43
44.
SPD/44
45.
SPD/45
46.
SPD/46
47.
SPD/47
48.
SPD/48
49.
SPD/49
50.
SPD/50
51.
SPD/51
52.
SPD/52
53.
SPD/53
54.
SPD/54
55.
SPD/55
SPD/56
57.
SPD/57
58.
SPD/58
59.
SPD/59
60.
SPD/60
61.
SPD/61
62.
SPD/62
63.
SPD/63
64.
SPD/64
65.
66.
67.
SPD/65
SPD/66
(TOPICAL SECTION)
SPD/67
SECTION)
68.
SPD/68
69.
SPD/69
70.
SPD/70
71.
SPD/71
72.
SPD/72
73.
SPD/73
74.
SPD/74
SPD/75
S.S.
SPD/76
SPD/77
SPD/78
SPD/79
SPD/80
SPD/81
SPD/82
SPD/83
SPD/84
SPD/85
86. SOP FOR CLEANING OF S.S. TANKS & STIRRER (LIQUID SECTION)
SPD/86
SPD/87
SPD/88
SPD/89
SPD/90
SPD/91
SPD/93
SPD/94
95. MILL.
SPD/92
SPD/95
SPD/96
SPD/97
SPD/98
SPD/100
SPD/101
SPD/102
SPD/103
SPD/104
SPD/105
SPD/106
SPD/99
Sign..
Sign.... Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.1.2
5.1.3
5.1.4
Sign..
Sign.... Sign...
5.1.5
5.1.6
5.1.7
TITLE: SOP FOR RODENTS, INSECTS & BIRDS CONTROL Page : 01-01
IN PRODUCTION
Deptt.: PRODUCTION
SOP NO.: SPD/02 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign..
Sign....... Sign...
1)
PURPOSE: To lay down procedure of control of rodents, insects and birds to be carried
out by the approved contractor.
2)
3)
4)
5)
PROCEDURE:
5.1
The approved contractor is deputing for control of birds, redents and insects by
applying the chemical. Birds repellents, nets sieves repellents i.e. UV repellent
(blue light), flycatcher, door nets are fixe on all entries. For insect control,
company has placed at all the entry-exit place, double door, one with wire mesh,
other with wooden & glass doors, with the facility of door closer.
5.2
Entries doors are installe with are Curtains to avoid entry of insects.
5.3
The contractor come twice every month or whenever called to review the
situation.
Sign..
Sign....
Sign...
PURPOSE
RESPONSIBILITY
ACCOUNTABILITY :
SCOPE
PROCEDURE
1)
5.1
Cleaning of pre-filter 20 micron average 7-15 days i.e. .weakly off day.
5.2
CLEANING:
6.1
Sign....
Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
1)
5.1
All the finished goods are carried to the disposal area in the final packed form.
Take out the inner carton from the shipper & finally take out the Tablets/ Capsules/
Oral Liquid/ Dry Syrup & Ointment from the inner cartons.
5.2
In case of Tablets/ Capsules/ Oral Liquid/ Dry Syrup & Ointment, submerge them
in water to dissolve & after dissolution, dump the slurry or solution into a ditch. In
case of Oral Liquid, break the seal of bottles, take out the liquid or solution into a
bucket & put it into the ditch. Glass containers & seals are kept separately for sale
as a waste. Shippers & inner cartons are burnt separately during packing material
disposal.
5.3
PRECAUTIONS :
6.1
6.2
Cartons or shipper or poly bags in which the finished materials were kept are
separated before disposal of finished goods and disposed off separately.
6.3
6.4
6.5
Page : 01-02
Deptt.: PRODUCTION
SOP NO.: SPD/05 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign..
Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
MAINTENANCE REQUIRED :
The following categories of the maintenance are generally required in a
Pharmaceutical formulation plant.
5.2.1
Civil Maintenance
5.2.2
Electrical Maintenance
5.2.3
Utilities Maintenance
The above categories are further classified as under to decentralize the work according to
need.
5.2.1 CIVIL MAINTENANCE:
This includes the following parts of maintenance in a building.
5.2.1.1
5.2.1.2
5.2.1.3
5.2.1.4
5.2.1.5
Page : 02-02
Deptt.: PRODUCTION
SOP NO.: SPD/05 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign..
Sign....
Sign...
5.2.2.2
5.2.2.3
5.2.2.4
5.2.2.5
1)
5.2.3.1
5.2.3.2
5.2.3.3
5.2.3.4
5.2.3.5
5.2.3.6
FREQUENCY
6.1
6.2
Paints: Once in 6 months in those areas where repair has been done.
Once in a year for the complete plant & factory.
2)
6.3
6.4
6.5
MAINTENANCE PROCEDURE:
7.1
The maintenance carried out when the production is not going on.
7.2
7.3
All repairs are carried out on request of the concerned Department Head in
writing and approval by the above referred authorized persons.
7.4
Sign...
Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
After completion of packing operation of one batch product, the packing line is
checked for excess packing materials.
5.2
Excess P.M. sorted out and good / without printed packing materials is counted and
tied.
5.3
All good material are returned to packing material store through material return
note.
5.4
All coded unit cartons/labels are transferred to scrap yard and shredded into pieces
before disposing off.
5.5
Details of all returned materials and rejected materials are recorded in packing
material reconciliation sheet included in Batch Production Record.
Sign..
Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
5.3
Then visitors & accompanying authorized person put shoe cover on his street
shoes or wear clean laboratory sleepers. They cross the barrier before entering
manufacturing area. After which they are dip the footwears in to the disinfecting
solution soaked mat and then into the main working area.
5.4
Before leaving the manufacturing area visitor remove the shoe cover, lab coat, cap
& mask and the concerned officer send them for washing.
Page : 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/08 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign..
Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
Page : 01-01
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1 Hand gloves and safety shoes are used in the manufacturing area. Enough, gloves,
etc. are available and used when required.
5.2 Lighting and electrical fittings are flame proof. In case of hot work, there is a system
to issue welding and fire permit (spark generating maintenance activity).
Page : 01-02
Deptt.: PRODUCTION
SOP NO.: SPD/10 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
Equipment:
a)
Name of Equipment.
b)
Code No.
c)
d)
Remarks, if any
e)
Lab Instrument:
a)
Instrument Name
b)
Sr. No.
c)
Date of Analysis
d)
Analysis time
e)
number
f)
A.R. No.
g)
h)
Signature
Signature of the person checking the analysis report.
of
analyst
Page : 02-02
Deptt.: PRODUCTION
SOP NO.: SPD/10 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
and
5.4
Sign...
Date of analysis
b)
c)
d)
Instrument Name
b)
Range
c)
Accuracy
d)
e)
Calibration Frequency
f)
Model No.
g)
Data repaired
Re-calibration data
Page : 01-03
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
5.3
Area
Temperature
Humidity
28-29O C
70% Max.
Blending, Compression
25-27O C
40-45%
23-25O C
40-45%
23-27O C
40-45%
Film Coating
25-27O C
50-55%
Corridors
25-27O C
70% Max
Page : 02-03
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
(b)
Director
Sign...
Beta Lactum
25-27O C
50% Max
25-27O C
50% Max
Other products
30O C
70% Max
25-27O C
50% Max
Chemical Laboratory
28-30O C
70% Max
25-27O C
50% Max
28-29O C
70% Max
25-27O C
50-55%
Laboratory
Page : 03-03
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
Area
Director
Sign...
Limit
Observation
Remarks
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
6)
PRECAUTIONS:
6.1
All scraps must be checked by House keeping Supervisor to ensure that no printed
packing material container or machine parts reach at the backyard.
Page : 01-01
Deptt.: PRODUCTION
SOP NO.: SPD/13 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
5.3
CORRUGATED BOXES
5.1.1
5.1.2
5.1.3
METALLIC CONTAINERS
5.2.1
5.2.2
GLASS CONTAINERS
5.3.1
5.3.2
5.3.3
Cross mark on label of the corrugated box with black marking pan.
5.3.4
5.3.5
Page : 01-02
Deptt.: PRODUCTION
SOP NO.: SPD/14 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
1)
2)
PURPOSE
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
The collected dresses are further categorized as per their color and utilization
and properly recorded in the log book available with the house keeping
department.
5.2
All the unclean dresses are then segregated as per their color and use and entered
in the log book prior to given for washing.
1)
CLEANING PROCEDURE :
6.1
6.2
The dresses are first observed for any oil spot or other chemicals to be
removed with solvent namely IPA / Ethanol, prior to washing.
6.3
The above treated dresses are then dipped in a soap solution at a temperature
between 40 to 45OC and rotated for 30 to 35 minutes.
Page : 02-02
Deptt.: PRODUCTION
SOP NO.: SPD/14 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
6.4
The above treated dresses are then squeezed and dipped in a drum of fresh
water and again rotated for 30 minutes and with another change of fresh water
these are placed for spinning stage.
6.5
6.6
6.7
6.8
All the cleaned dresses are then received and recorded in the Logbook.
6.9
The cleaned dresses are then segregated as per their colour and requirements
and kept in the appropriate cupboard making entry in the logbook.
6.10
The above cycle is continuously monitored and dresses are issued to each
department by Signing in the logbook.
6.11
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
FREQUENCY
6)
PROCEDURE
6.1
6.2
Empty waste bins and reline with plastic bags when necessary.
6.3
Wash sink and waste pipe using 0.1% Teepol solution in water and wipe dry.
6.4
Wash interior surface of commode bowl using bowl cleaner solution with a bowl
mop. Wash exterior surface of bowl seat using 0.1% Teepol solution in water.
6.5
Damp mop all accessible are using lint free or rubber lined handle mops initially
with a 0.1% Teepol solution in water then with plain water and finally with a
disinfectant solution.
Bucket 1 To squeeze out the dirty water from mop.
Bucket 2- To Contain clean water for rinsing the mop.
6.6
6.7
6.8
6.9
Flush out the drainage channel after removing any solid debris.
Sign...
6.10
6.11
6.12
Rotate the disinfectant to be used on daily basis and record the same in daily
cleaning.
6.13
6.14
Carryout the cleaning operation as and when necessary to ensure the aera as clean
and hygienic.
6.15
Fill the daily cleaning and sanitation record and get it Signed.
Weekly Schedule:
1. Clean the wall using sponge impregnated with 0.1% Teepol solution in water.
2. Wipe down the handrails, stairways with an approved disinfectant solution.
3. Dedust all the shelves, floors and walls of change rooms, the storage and weighting
area using a sponge.
4. Damp wipe all surfaces with 0.1% Teepol solutions in water after moving out any
movable equipment such as container, weighing balance.
5. Damp wipe the accessible parts of intercom with sponge or cloth.
6. Damp wipe the doors, push plates, view panels and glasses with a spray of aerosols
cleaner (Colin) and wipe dry.
7. Dedust exhaust fan, light fixer with sponge or cloth.
8. Damp wipe all other fixer with a sponge or cloth using 0.1% Teepol solution in water.
9. Hose down the passages with plenty of water. Flush out the water.
TITLE: SOP FOR CLEANING AND SANITATION OF
Page : 03-03
GENERAL AREA PRODUCTION BLOCK
Deptt.: PRODUCTION
SOP NO.: SPD/15 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
Monthly Schedule
1)
2)
Apply the floor finish on clean and dry floor and rub it to polish.
3)
Clean wipe the light diffuser and U.V. Light tube with a wet cloth.
4)
Page : 01-02
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
6)
CALIBRATION :
6.1
Switch off the electric supply to the balance, in case of an electric balance.
6.2
Clean the pan/ platform of the balance with a brush. If required cleaning is done
with clean cloth dipped in 0.1% Teepol solution followed by clean water.
6.3
Check the level of balance and ensure that the balance is properly leveled.
6.4
Select the standard weights for various weighing balance based upon the capacity
of balance to be calibrated.
6.5
In case of electronic balance switch ON the balance, adjust the balance whether
electronic or mechanical to zero. Place standard weight s one by one on the
platform/ pan. Record the rading in respect calibration record. These records are
available at weighing station.
6.6
Check that the observed weights are within the limits, as given in this SOP.
6.7
If the error is more than acceptable limits, the error is rectified before the balance
is to be used.
6.8
Do not use the balance if the error is not rectified. Inform the Production
Executive and call the Service Engineer.
Balance Capacity
200 gm
6 kg
60 kg
100 kg
Standard Weight
1.00 gm
400 gm
5 kg.
5 kg.
Standard Weight
10 gm
5 kg.
10 kg.
50 kg.
Acceptable Limit
+0.1 % max.
+0.25% max.
+0.25% max.
+0.25% max.
Sign...
OPERATION:7.1
7.2
Clean the pan of the balance with brush. If required, Teepol solution 0.1%
followed by D.M. water and wipe dry with clean cloth.
7.3
7.4
7.5
7.6
In case of electronic balance, press the ON switch on the digital control and
wait till it indicates ZERO. In case of mechanical balance check ZERO reading.
7.7
7.8
Place the material on the balance platform / pan by one and check. Check the
weights against requisition slip and batch production record.
7.9
Material tags are tally with the details on Batch Production Record. Checks tally
the name of material, A.R. No., gross weight, tare weight and net weight of
material.
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1)
CLEANING :
5.1.1
5.1.2
Dismantle all the supporting plates & lock plates from the machine
dip in water.
and
5.1.3
Remove the powder from the machine by the Nylon brush. Transfer
all parts to washing area. First clean with 0.1% Teepol solution or
equivalent soap solution by moping with non woven cloth.
5.1.4
5.1.5
5.1.6
5.1.7
Sign...
OPERATION:5.1.1
5.1.2
After getting QC report, reassemble the capsule machine for filling of next
batch (Product).
5.1.3
5.1.4
Weigh qty. of powder to be filled for 300 capsules. Put the powder on the
capsule magazine, spray the powder by a plastic made spreader.
5.1.5
5.1.6
Load the caps part of the capsules, and lock the plate by pressing with
handle.
5.1.7
5.1.8
5.1.9
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
Clean the blister packing machine with Teepol solution (0.1%) or eq. soap
solution by nylon cloth / foam.
5.3
Remove the blister forming roller, ink device, hopper, chute, channel,
plate ,sealing roller etc.
5.4
Clean them with Teepol solution (0.1%) or eq. soap solution by nylon
cloth / foam.
5.5
5.6
Clean the conveyor belt with the Teepol solution (0.1%) or eq. soap
solution by nylon cloth / foam.
5.7
5.8
5.9
Proper oiling and greasing in the machine are necessary before installation
of machine.
5.10
Sign...
6. OPERATION :
6.1 Before the starting of the machine check the sealing roller, forming rolls, guide track,
chute, hopper etc.
6.2 Open the valve of compressed air and raw water.
6.3 Fill the ink pot with the ink, and fix the stores.
6.4 Start the temperature heating element and roller forming switch.
6.5 When temperature reaches at approx. 160OC, fix the blister/ PVC roll and printed
aluminum foil of the required product.
6.6 Now start the machine to check the forming cavity and sealing of blister strip.
6.7 Load the hopper with tablets/ capsules for commercial packing.
6.8 Check the sealing by Leak Test method.
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
5.3
Remove the gasket and top of the mouth from the cone blender, dip in a soap or
Teepol solution (0.05%).
5.4
Clean the cone blender with 0.1% Teepol solution by moping with non woven
cloth.
5.5
5.6
Mop the external parts of the cone blender/ frames by the non woven cloth.
5.7
After complete cleaning of cone blender send wash water sample for analysis.
Page : 02-02
Sign...
OPERATION:6.1
After getting the wash water report, fix a label MACHINE IS READY
FOR USE.
6.2
6.3
6.4
6.5
6.6
CAUTION: Before starting of the machine, keep distance at least 3 ft. from the machine to
avoid the accident.
Page : 01-02
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1)
CLEANING:5.1.1
5.1.2
Loosen the bolt, remove the lock of hopper of dry syrup filing
machine.
5.1.3
5.1.4
5.1.5
5.1.6
5.1.7
5.1.8
Clean the external machine parts and body with DM Water by wet
moping and dry the machine.
5.1.9
Finally rinse with DM Water and send a sample of wash water to the
Q.A. department.
5.2)
Sign...
OPERATION
5.2.1
After getting the result form Q.A. department fix a label MACHINE IS
READY FOR USE.
5.2.2
Reassemble all the dismantled parts of the machine i.e. auger, weight
wheel, hopper etc.
5.2.3
5.2.4
Start the machine and check the weight of fixed quantity of each bottle.
5.2.5
5.2.6
5.2.7
Checking of weight variation of filled dry syrup bottles is done after every
30 minutes.
5.2.8
Page : 01-01
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
CLEANING:5.1.1
5.1.2
5.1.3
Dismantle the sealing die. Clean with the dry cloth dipped in diesel to
avoid the rust from environment.
5.1.4
5.1.5
5.1.6
5.2
Reassemble the die. Finally clean the machine with dry cloth.
OPERATION:5.2.1
Adjust the height of bottle with ROPP cap dry inching method.
5.2.2
Check the sealing of 10 dry syrup bottles for good quality of sealing.
5.2.3
Adjust the guide of the bottle pressing plate / lifting plate with sealing
die.
5.2.4
5.2.5
Page : 01-01
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
General Rules :
5.1.1
5.1.2
5.1.3
5.1.4
Page : 01-01
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
a)
b)
c)
Moping the floor and working table with hot 0.1% Teepol solution
Clean the melting and compounding vessel with hot 0.1% Teepol solution.
Scrub the vessel, cover, agitator, scrapper with nylon scrubber to remover
trace of the pervious product.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/24 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
Line clearance operation is recorded in prescribed format and duly signed by Q.A.
Manager/ Production Manager.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/25 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
Test and release filled bottle of the product received from quarantine area to visual
inspection area.
5.2
Depute the visual inspection team for proper checking of fiber / glass / black white
particles and any foreign matter.
5.3
5.4
The complete visual inspection team is divided into 2 group of expert team.
5.5
5.6
5.7
The visual inspection team personnel are needed maintained accordingly to ensure
the proper checking of foreign matter.
5.8
5.9
Page : 01-01
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
A.
B.
C.
B1
Capsules/ Tablets
B2
Dry Syrup
B3
D2
1st and 2nd place are denote product code as per attached list e.g.
D3
3rd and 4th place are denote serial No. of batch e.g. 02 denotes 2 nd
batch of the year of that particular product.
Page : 01-01
Deptt.: PRODUCTION
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
The recoverable bottle of the different batches are collected and reported in new
flow sheet with a batch no., batch size and expiry date must be mentioned of the
first batch of recovery.
5.2
The bottle are collected and transferred in a clean area and reopened and solution is
collected in a S.S. closed container.
5.3
Nitrogen flushing of the recovered solution is done till the batch is filled.
5.4
Recovered bulk solution is sent for testing to check the pH, assay and other tests as
required.
5.5
After getting the approval from the Q.A. Department recovered solution is
filtered through sterile membrane filter in a sterile filling vessel.
5.6
Filtered solution is filled as a new batch and new Batch No. M/D, E/D, is
mentioned in each and every stage.
5.7
The expiry of the new batch is the expiry of the oldest recorded batch.
5.8
Recovery details are to be recorded in the presented format of the Batch Record.
Page : 01-02
Deptt.: PRODUCTION
Review Date: 14-07-2009
Checked By:
Production Manager
Approved By
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
Place the sample into a vacuum dessicator containing enough water to cover the
sample with at least one inch of water (measured from the top surface of
package). Use a metal grid or screen to hold the sample submerged.
5.3
Close the dessicator and slowly apply 10 inches (25 cm) of vacuum as read on a
vacuum gauge, taking between 30 seconds and one minute to raise the vacuum.
Hold under vacuum for 3 minutes. Present the vacuum line for 10 inches of
vacuum by means of valve.
5.4
5.5
Page : 02-02
Deptt.: PRODUCTION
Sign...
5.6
5.7
If one pocket shows evidence of leakage, reject the sample, stop the line, and
immediately notify the packing line supervisor so that corrective action may be
taken.
5.8
5.9
Record the results of all tests in the packing record, indicating the time tested, the
sample size, the number of leaking samples, found, the corrective action taken
and the result of further testing.
Page : 01-03
Deptt.: PRODUCTION
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
1.
Use clean nylon brush and wipe with clean dry lint free duster.
2.
3.
Dismantling Remove:-
(a)
(b)
(c)
Cleaning of parts:Clean the above parts by washing with 0.1% Teepol solution and scrubbing with
soft nylon brush. Rinse with jet of potable water followed by rinsing with D.M.
water. Clean loading platform with wet duster. Clean back and front cover and
empty capsules hopper using clean dry lint free duster.
Page : 02-03
Deptt.: PRODUCTION
Review Date: 14-07-2009
Checked By:
Production Manager
Approved By
Q.A. Manager
Director
Sign...
Drying:The cleaned parts as mentioned in step 3 are wiped and dried using clean dry lint
free duster.
5.
Assembling:Reassemble all the parts of the machine carefully checking the correctness of
assembling.
Note:
6.
5.1
5.2
If the cleaned loader is not used within 24 hours after cleaning or there are
sign of dust or powder settled on loader, then wipe the body by using a
freshly laundered lint free duster.
6.2
6.3
6.4
CAUTION: In case of any abnormal sound from machine during its operation, stop the
machine and report to maintenance.
Page : 03-03
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
8.
9.
10.
Director
Sign...
ASSEMBLING:7.1
7.2
7.3
7.4
OPERATION:8.1
Ensure that all parts of machine are cleaned as per standard procedure.
8.2
8.3
8.4
8.5
DISMANTLING:9.1
9.2
9.3
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1)
5.2)
5.3)
5.4)
5.5)
5.6)
The water storage SS tank is thoroughly washed and cleaned with 0.1% Teepol
solution and finally with DM Water.
5.7)
1st ice formation takes place on the inner surface of Pre-filter. Get it cleaned by
spraying hot DM Water spray and finally get it dried by blowing warm air
current.
Sign...
OPERATION:6.1
Ensure that all parts of machine are cleaned as per standard procedure.
6.2
Check the manufacturing area from the point of exposures and disturbances.
6.3
Switch on mains of electricity supply after all setting of its implements, if area
is found perfect.
6.4
6.5
6.6
6.7
6.8
CAUTION: In case of any abnormal sound or disturbance from machine during operation, stop
it and report to maintenance for overhauling.
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
CLEANING:
5.1.1
5.1.2
5.1.3
Remove the strip forming roller, ink device, hopper, chute, channel,
plate, sealing roller etc.
5.1.4
Clean them with Teepol solution (0.1%) or eq. soap solution by nylon
brush/ brass brush.
5.1.5
5.1.6
5.1.7
5.1.8
5.1.9
OPERATION :
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
5.2.6
Now start the machine to check the forming cavity and sealing of
strip.
5.2.7
5.2.8
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/32 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
a)
SS feed hopper
b)
c)
5.1 Remove all the residual powder adhering to the above mentioned articles with the
help of a nylon brush.
5.2 Wash these articles with hot water.
5.3 Wash these articles with 0.1% Teepol solution.
5.4 Clean these articles with running water to remove all traces of detergent.
5.5 Drain off all the water and dry all the articles.
5.6 Clean the exterior of the sifter stand and motor assembly with the help of a lint free
wet cloth.
5.7 Carry out step 1 to 5 for the SS base plate with discharge outlet attached to the sifter
stand.
5.8 Assemble all the cleaned / dried articles from step 5 on the Sifter stand frame.
TITLE: SOP FOR CLEANING & OPERATION OF SIFTER
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/32 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
7.
Sign...
b)
c)
d)
Date of cleaning.
e)
Supervised by
OPERATION:
7.1
Before starting the shifting operation, ensure that the machine is clean.
7.2
7.3
Tie polybags kept in SPD/Plastic drums to the outlet of Sifters with the help of
twine.
7.4
7.5
After the drum is filled to 80-90% capacity, tie the polybag, close the lid of drum
and fix identification label on it showing the Name, Batch No. & Batch Size of
the product.
7.6
7.7
7.8
Page : 01-03
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
Director
Sign...
5.1
5.2
If the product has remained in the above stores for a longer period then on the
request of store In-Charge, the goods are sampled and subjected to stringent
inspection and required analysis by Q.C. Department.
5.3
5.4
Samples collected from the stores and sent to the Q.C. Department for analysis
Within 15 days along with format test reports are reported. The operation on the
suitability or otherwise of product for distribution is also forwarded along with
analysis report by Q.C. Manager to the store In-charge.
5.5
5.6
If the results are unsatisfactory the product returned by the stores in charge to the
factory for reprocessing and repacking if required, immediately after the receipt of
the Q.C. report.
5.7
5.9
Sign...
Serial No.
5.8.2
5.8.3
5.8.4
Quantity involved.
5.8.5
5.8.6
Stock in hand.
Serial No.
5.9.2
5.9.3
5.9.4
5.9.5
Date of receipt
5.9.6
5.9.7
QA Managers opinion
5.9.8
Quantity destroyed.
5.9.9
5.9.10
5.10
5.11
Sign...
5.12
Goods lying in the transporters go-down or received back by the depot from
market.
5.13
The product inspected for physical damage, if any on receipt from the
transporters go-down by the stores in-charge at the branch depot, based on the
type and extent of damage. The branch personnel are further action.
5.14
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/34 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
5.1
After issue of packing material from warehouse, check for identity and quantity.
5.2
5.3
Before starting of operation the labels and cartons are checked for any defect.
Check identity of product & Quantity of product before starting of packing
operation.
5.4
Before starting fresh batch all material required are brought and kept at relevant
place only.
5.5
5.6
5.7
Deliver the goods to the warehouse only on receipt of final approval from Q.A.
5.8
Disposal of excess labels, cartons and records is done as per SOP No. SPD/12.
5.9
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/35 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
5.1
The General Utensils like S.S. Container, S.S. Scoops, and S.S. Trays etc. are
washed with water.
5.2
Wash with liquid soap or detergent with gentle rubbing. Then wash with fresh
water until the detergent foam is completely washed out.
5.3
Finally wash with DM water and get wash utensils checked from the Q.C. lab.
5.4
Sign...
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
5.1
5.2
5.3
Clean all the machine parts using potable water. Then wash with 0.1% Teepol
solution. Then rinse with potable water and then rinse with D.M. Water.
5.4
Finally rinse with D.M. water and send the wash water to Q.C. Department for
analysis.
5.5
5.6
After getting O.K. report from Q.C. Department, put a tag on machine CLEAN
& READY FOR USE.
Sign...
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
5.1
The people who are sick & ill or suffering from any disease are not permitted in
production area.
5.2
5.3
If any person feels discomfort in the production area or feel ill then inform
immediately to concern supervisors / in-charge.
5.4
As a fixed policy of organization, the people are shifted outside the production area
under medical aid.
PURPOSE
Sign...
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
Q/C Manager.
Production Manager/Q.A. Manager
5.1
Paste Material under Test printed yellow sticker on all the containers, of that
material, which are under test.
5.2
Paste Approved slip printed green sticker on the entire container, of those
material which are Tested by Q.C. Deptt.
5.3
Paste Sampled printed sticker on those containers, whose content are sampled.
5.4
Paste Rejected printed red sticker on those containers, which contain rejected
material.
5.5
Sign...
Sign...
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
5.1
5.2
Check and certify that the requisition slip is correct in all respect and get it
authorized from production manager.
5.3
5.4
Receive the issued material through the packing store material gate of production
block.
5.5
Physically check and count all packing material received against requisition slip.
5.6
Acknowledge the receipt of material on requisition slip and file the departmental
copy of BPR.
5.7
Stock the issue quantities properly in a manner to avoid damage due to over
loading or fall down.
5.8
Store the received labels in cupboard and other printed packing components in a
locked room. Restrict the access to this area.
5.9
5.10
Sign...
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
5.1)
Rejected Material:
a)
b)
c)
5.2)
Expired Materials: Input materials or finished product which has lost its
credential due to non-usage for a period of over the years.
5.3)
Unusable Materials:
a)
b)
All rejected, expired and unusable materials are pasted with red stickers,
so that they can be identified and are physically separated from the other
materials.
c)
These materials are kept either in its original packing or in double poly
bags duly knitted or sealed and bearing a sticker (red) with following
informations.
Sign...
REJECTED
Pack No.______________
Raw Material___________________________________
Batch No.______________________________________
Date of Mfg.____________________________________
Date of Exp.____________________________________
Qty.___________________________________________
Mfg. By________________________________________
Supplied By_____________________________________
Test Date_______________________________________
Analytical Report No._____________________________
Control Ref. No__________________________________
Failed Parameter_________________________________
Sign...
1)
2)
In-charge of Production.
The record of such goods disposal are maintained in the following format.
S.No.
Material
Date of
Disposal
/Salvage
Signature of
I/C Q.A.D.
Signature of
I/C Prod Deptt
b)
c)
Every fortnight water is poured in the pit, so that over the years, the material
become part of the earth itself.
PURPOSE
Sign...
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
5.3
5.4
Sort out the waste from packing section in presence of packing supervisor.
5.5
5.6
5.7
PURPOSE
2)
RESPONSIBILITY
Sign...
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
As soon as the coating operation is over, remove the coated tablets in suitable
containers. Remove the dry powder from the pan, if any.
5.2
Pour approximately 20 liters of hot water (80-85OC) into the pan and allow the pan
to rotate for about 10 minutes. Remove this turbid water using a plastic mug and
transfer it into a plastic bucket. Clean the inner surface of the pan with angular
wooden brush having nylon bristles.
5.3
Place about 500g of sodium bicarbonate into this pan and gradually put about 20
liters of hot water (80-85OC) into the pan taking care that the eyes are well
protected by goggles and full size PVC gloves are worm to cover arms. Allow the
pan to rotate for 10 minutes. Remove this turbid water.
5.4
Place about 10 liters of warm water (40-45OC) into the pan. Allow the pan to rotate
and continue to clean the inner surface of the pan with the angular wooden brush
having nylon bristles. Remove the water and check that the inner surface of the
pan is free from any powder of foreign particles.
5.5
Place approximately 10 liters of warm water (40-45 OC) into the pan and allow the
pan to rotate for about 5 minutes. Remove this water. This rinse water is free from
alkali. Repeat rinsing with 10 liters of warm water until the rinse water is free
from alkali as indicated by a pH paper.
5.6
Allow the pan to rotate and wipe the inner surface of the pan with a lint free cloth.
Look for any scratch pits on the inner surface of the pan.
Sign...
Cover the mouth of the coating pan with a nylon lid, affix the cleaning ticket
indicating the following.
- Equipment / Machine
- Last Production -
Batch No.
Batch No.
- Cleaned by
- Date
- Signature.
6)
BLOWER ASSEMBLY:
A
B.
2.
Cleaning of blower pipe Clean the blower pipe from inside and outside
using compressed air. Wipe the external surface with a duster.
3.
Cleaning of the blower body Wipe the external surface with a duster.
2.
Cleaning of blower body Clean the body surface, motor and fan using
compressed air from outside as well as inside. Deduct the external surface
with a duster. Wipe it with wet duster and dry it with a duster.
3.
Cleaning of blower pipe First clean it from inside and outside with a jet
of potable water using a soft nylon brush. Then clean with 0.1% Teepol
solution and again with a jet of potable water. Finally rinse with DM
Water.
4.
b)
c)
d)
e)
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/43 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
Cleaning external surface and plenum: Clean the body of the drier
and plenum with a dry clean duster. Then wipe it with a duster soaked in
0.1% Teepol solution followed by a duster soaked in D.M. Water.
2.
Dismantling:
a)
b)
c)
d)
Remove bowl.
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/43 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
3.
Assembling Fix the laundered finger bag in a metallic hanger around the
retiring chamber. Clamp the retarding chamber on the body with the fixed
bolts. Lift the bottom of FBD. And seal the trolley with bowl to the
retarding chamber.
Note: 1)
2)
B.
6)
Clean the body of the drier and plenum with a dry clean duster.
6)
6)
Wipe the interior of the retarding chamber and bowl with a clean dry
duster.
6)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
5.2
Operation
5.3
STAGE I
a)
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
d)
e)
A plastic bag having two sides opening are tied to the delivery chute.
f)
g)
Sign...
STAGE II
a)
The multi-mill is switched on and run for few seconds to observe whether if is
running normally or not.
Fix knives in rotor as per requirement of sizing i.e. impact edge or knife edge
forward.
c)
Ensure that blades fixed in the rotor are in 4, 3, 4, 3, sequence and none of the
blades are missing. Fix the key to the central shaft.
d)
Fix the rotor with blades to the central rod of multimill with rotor fixing screw.
e)
Fit the required intact screen base plate on multimill properly tightening two sides
nuts.
f)
Fix the belt on the appropriate wheel of the pulley, so as to get required speed fast,
medium or slow. Give proper tension to the belt by moving movable pulley apart
and lock it in position.
g)
Check the knives of the rotor are not touching the screen by turning the belt by
hand.
h)
i)
j)
If any abnormal sound is heard the machine is referred to maintenance dept. for
rectification.
k)
In other case the machine is started and the mass is put on the hopper slowly and
gradually.
l)
The granulated mass is collected in the poly bag kept in fiber drum.
m)
n)
Sign...
o)
In case of batch changes the contact parts are cleaned by clean cloths.
p)
In case of Product or composition change the entire m/c is washed and wash water
analysis is to be done to by Q.C.D. render the m/c ready for further use.
STAGE III
After the days operation or Production change or change of composition all the
contact parts like cutter knives, screen, cover and hopper etc. are thoroughly
cleaned using liquid soap/detergent and wash the machine till foam of
detergent/liquid soap completely washed out. Finally wash with D.M. water and
wash water is sent to Q.C.D. for testing.
b)
Place a new polythene bag in a clean plastic container and tie to the bottom of the
multi-mill chamber.
c)
Load the material to be milled into feeding hopper by means of a clean SS scoop
with handle.
d)
NOTE: When the container is full, switch off the mill and the untie the poly bag from the
mill chamber. Tie the bag and fix appropriate label to the container. Repeat the
procedure as often as required, always fixing the container in similar manner to the
discharge chamber of the mill
e)
At end of the milling operation, switch off the mill and disconnect the electrical
mains.
NOTE: The dismantled parts are cleaned on the same day of the operation. If the mill is
to be used the same product, do not dismantle but tie a fresh poly bag on bottom of
milling chamber, awaiting a new load for milling. If any unusual noise is heard during
the milling operation, stop the machine to remove the receiving container. Dismantle
the mill and note the cause of noise. Inform the maintenance department of the problem.
Quarantine the mill as well as the container pending further packing.
f)
Once the wash water analysis is cleared by Q.C.D. The contact parts and other
parts are moped and dried.
Page No.:.......
Machine/Equipment Code:
Location:.........
Date
Start
Time
Finish
Time
Total Hours
of Running
Break Down
START END
Down Time
Hours
Production/
Batch No.
Operated
By
Checked
By
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/45 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
PRECAUTION
6.2
6.3
Remove excess wax by scrapping with the knife and then clean with a nylon brush.
6.4
6.5
6.6
Cover the equipment with a fresh cloth over till the commencement of the next
operation.
6.7
Equipment/ Machine
Last Product
Cleaned by
Date
Signature
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.2 Clean the parts by washing with 0.1% Teepol solution and scrubbing with soft
clean nylon brush. Rinse with potable water followed by rinsing with DM
water.
5.3 Clean the capsule plates by soaking in hot water for 10 minutes. The holes are
cleaned using 0.1% Teepol solution. Rinse with potable water followed by
rinsing with DM water.
5.4 Clean the machine body with 0.1% Teepol solution & scrubbing with soft
nylon brush. Then rinse with potable water.
5.6 The cleaned parts are dried using clean lint free cloth. The capsule plates are
air dried
TITLE: SOP FOR CLEANING AND OPERATION OF CAPSULE Page : 02-02
FILLING MACHINE (SEMI-AUTOMATIC)
Deptt.: PRODUCTION
SOP No.: SPD/46 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
6)
Sign...
OPERATION:
6.1
6.2
After getting QC report, reassemble the capsule machine for filling of next
batch (Product).
6.3
Weigh qty. of powder to be filled for 300 capsules. Put the powder on the
capsule magazine; spray the powder by a plastic made spreader.
6.5
6.6
Load the caps part of the capsules, and lock the plate by pressing with
handle.
6.7
6.8
6.9
PRECAUTIONS: Rejected capsules are separately packed in a corrugated carton and labeled as
REJECTED and transferred to quarantine area.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/47 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
Dismantling: - Remove the gun from stand. Dismantle parts of the gun (aircap/needle/nozzle).
5.2
Cleaning of gun:
a.
Dip the gun is SS bowl containing hot potable water, for about
hour.
b.
c.
d.
Scrub the external surface of gun air cap and needle with 0.1%
Teepol solution. Rinse with potable water.
e.
f.
g.
5.3
Drying of the Gun body: Wipe the dismantled part and body of the gun with
lint free duster.
5.4
Storage: - Store the gun and its part in an appropriate clean poly bag until use.
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/48 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
PURPOSE
:
Cleaning of the floor and wall surfaces in the non-sterile
manufacturing area help in removal of the accumulated dust disinfection of the area. This
is essential keeping in view the need to preclude any contamination of formulation
processed in the manufacturing area. Cleaning and disinfection of the non-sterile
manufacturing area is a primary requirement of GMP and is of utmost importance since
the particles are continuously generated during the operations contaminating the entire
area. The viable /non viable particles settling on the equipment not in use, walls, floors
may lead to potential cross contamination if the effective cleaning procedures are not
followed.
6)
FREQUENCY: Cleaning and disinfection of the non-sterile area used in order to prevent
development of resistant strains of the common contaminating microorganisms.
7)
8)
AREA COVERED: Granulation, coating, drying compression, strip & blister packing
and passages.
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/48 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
9)
Sign...
12)
PROCEDURE:
a.
b.
Cleaning of the floors and the walls is done at the end of the day
or shift only after all the equipment/ machine / containers have cleaned and
suitably covered.
c.
Initially clean with vacuum cleaner all the floor and wall edges to
dislodge any accumulated dust in the crevices.
d.
The entire floor is then cleaned with water and disinfecting agent
of the specified concentration and subsequently the floor is dried.
e.
f.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/49 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
SCOPE
5)
PROCEDURE
5.1
5.2
Pour the required quantity of material into the vessel as per sequence specified in
the product batch manufacturing record.
5.3
5.4
5.5
5.6
5.7
Clean the paste vessel daily as per defined standard operating procedure.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
POLYTHNE BAGS: All discarded poly bags are collected in container labeled as
Used Poly Bags slip and send to scrap yard.
5.2
LABELS: Discarded labels are collected in container labeled as Used Poly Bags
slip and send to scrap yard along with poly bag by house keeping person. Labels
of dispensed raw material are teared off and then discarded as above only after the
batch is released for packing.
5.3
REJECTED TABLETS: Rejected tablets during the initial run from compression
machine are destroyed in a bucket of water. All In-process checked tablets during
compression and coating are destroyed in Bucket of water.
5.4
DUST: Dust is collected by vaccum cleaner and machine dust collector. Put it in a
poly bag and then discarded by putting it in water.
Discarded punches, damaged finger bags, bowl cover, sieves and screens are handed over
to stores on the scrap note after approval by Production & Safety In-charge. The
embossed punches are to be defeated under the supervision of Production Manager.
These materials are then transferred to scrap yard for destroying.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
1)
2)
Feed hopper
Acrylic guards
Feed-frames.
Turret guards
Die screws
Clean all the above mentioned parts along with relevant bolts thoroughly with hot
tap water and keep them aside.
a)
Remove carefully all the lower punches by removing the plug and keep these
punches in a specially designed wooden tray, serially arranged. Similarly remove
all the upper punches and keep them in a separate wooden tray serially arranged.
Remove all the dies with the help of SS rod and keep them serially arranged in a
one of the above trays.
Sign...
Clean all the interior area of the machine like base plate on which the turret is
fitted, cam tracks, die seats , upper and lower punch holes turret surface, first with
a dry nylon brush and then with denatured spirit (70% I.P.A.). Care are taken with
cleaning the punch hole and die sets so that they are free from any particulate
matter.
Wipe clean the exterior of the machine with a lint free duster.
d)
e)
Use 15 liters of distilled water to give couple of washing to the cleaned parts and
the dismantled punches and dies. Inspect the final rinse water for absence of any
suspended matter. If required use additional distilled water to get the clear rinse
water.
f)
Wipe all the cleaned parts from step e with a clean dry lint free cloth.
5.1
FITTING OF DIES: - Before the dies are fitted, ensure all the die seats are free
from any foreign matter place the die face downwards on the die hole. Apply light
pressure with fingers on the top phase of the die to locate centrally over the die
hole. After locating the die correctly, drive the die position with the help of SS
rod introduced through the upper punch guide holes. Once the die is fitted the top
portion of the die flushed with the turret surface.
Sign...
FITTING OF LOWER PUNCHES: -Take a lower punch and wipe its dry
smear with liquid paraffin and introduce it through the lower punch die hole
taking care that each numbered punch goes into its corresponding compression
station. All the lower punches thus introduced are move freely up and down. Put
the plug back into its position. Fix all the cleaned and dried nylon plugs with
spring steel strips.
FITTING OF UPPER PUNCHES: -The cleaned and dried upper punches are
smeared with liquid paraffin and introduced them in to their respective holes:
A)
Put back all the turret guards after wiping them dry. Fit the cleaned and
dried feed frame at their respective positions. Install the cleaned and dried
acrylic guards and hoppers in their relevant position.
B)
Cover the cleaned machine with a clean cover. Affix a cleaning ticket
indicating the following:-
Equipment / machine
Last Product-
Batch No.
Batch No.
Cleaned by
Date
Supervisor Signature
TITLE: SOP FOR TABLETS COMPRESSION TOOLING
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/52 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
SCOPE
5)
PROCEDURE
The quality of the tablet significantly dependent on the condition and quality of the tooling used
for compression. The tablet compression tooling consist of a set having I upper punch, I lower
punch and die. The concerned Production Manager maintain the following data of the
compression machine (for which the tooling is to be used.
Name of the Compression Machine (for which tooling set is to be used)
Name of the product (for which tooling set is to be used)
Number of Upper Punches
Number of Lower Punches
Name of the manufacturer (of the tooling set)
Date of the manufacturer ( of the tooling set)
Details of tools received (No. of upper punches, lower punches & dies)
Date on which the tooling set was put to use
5.1 TOOLING USE LOG:Date
Product
Initials of Supervisor
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
A)
GRANULES: -At the end of granulation process, the lubricated granules are
unloaded in suitable no. of Pre-shifting weighed aluminum / plastic containers
with polythene bags, up to approx. 80-90% holding capacity of the bags to
facilitate proper tying with twine. A label indicating product, batch no., S.No. of
container & total no. of the containers for the batch are affixed on the inner side
of the lid and one on the exterior of the container. All the containers are weighed
again to determine the net wt. of granules. These containers then transfer to
quarantine area and stored on SS pallets in 2 roll with maximum height of 2
containers having label on the front side. The containers of different batches are
segregated.
B)
TABLETS: - Compressed tablets from the machine are stored in suitable no. of
labeled, pre weighed aluminium / plastic containers with polythene bags, up to
approx. 80-90% holding capacity of the bags to facilitate proper tying with twine.
The label which are affixed on the inner side of the lid and on the exterior of the
container with the detail about product, Batch No., S.No. of container & total No.
of the containers for the batch. At the end of the compression process all
containers are weighed again to determine gross wt. and consequently the net wt.
of tablets. The containers are transferred to quarantine area and stores in stacks of
four containers not more than three rows per batch having label on the front side
of the containers.
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/54 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
CAUTION: i)
Check and certify that area and equipment are clean and suitable
for starting the operation.
ii)
A.
ASSEMBLING:
1.
2.
3.
Fix the finger bag in a hanger. Fix the loops of the finger to the
hooks of the shaker.
4.
5.
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/54 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
B.
Sign...
OPERATION:
1.
2.
Move the product bowl in the retarding chamber keeping the window
in viewing position.
4.
5.
Lift the bottom of the FBD moving the jack handle to the opposite
side and seal the trolley to the retarding chamber.
6.
7.
Set the timer and switch on heating and fluidization, maintaining the
desired inlet air temperature.
8.
Stop drying at intervals and dedust the finger bag by shaking it.
9.
Take out trolley and shake the granules to avoid formulation of lumps
C.
UNLOADING:
1
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
:
The entire Machine Operation is divided in three stages.
I)
Pre-operative Cleaning & Setting.
II)
Operation
III)
Post Operative Cleaning and equipment preparation.
Stage I
a) The shaft, Blade, Cover and inner & outer surface of the machine is cleaned with
dry cloth.
b) The electrical connections are restored by pulling the plug top into the socket.
c) Clean the lid and vessel of the mixer with tap water.
d) The mixer is rinsed with hot tap water, to remove adhered lumps of powder, keeping
it in tilting position.
e) Pour approximately 100-liter water into the mixer. To it add 100 ml of Teepol
solution and run the mixer for 15 minutes. Then use nylon brush to remove any
adhered material.
f) Ensure that no material is adhered to the corner and edges of the shaft.
g) Remove the water and rinse with fresh DM Water and dry it by using clean muslin
cloth.
h) Collect the rinse of the final checking and send to QC Department for checking of
contamination from previous product.
i) Paste the specified CLEAN SLIP label after getting approval from QC Department.
j) Cover the mixer lid, when in use.
Sign...
B)
Stage II
a) The Mass Mixer is switched on and run for few seconds to observe whether it is
running normally or not.
b) If any abnormal sound is heard the machine is referred to maintenance deptt. for
rectification.
c) In other case the Bulk (Sieved powder) put into the mass mixer, covers the
machine and starts the machine.
d) After mixing the content for required time (e.g. for 30 minutes).
machine then add the binder (paste).
Stop the
e) Run the mixer for further 15 minutes and get the required wet mass. This wet
mass is now ready for milling. Collect out the mass in S.S. Container.
f) If further granulation of the same product is required it is continued.
g) In case of product or composition change the entire machine is washed and wash
water analysis is to be done to by Q.C.D. render the machine ready for further
used.
TITLE: SOP FOR CLEANING AND OPERATION OF MASS Page : 03-03
MIXER
Deptt.: PRODUCTION
SOP No.: SPD/55 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
Stage III
a) After the days operation or Production change or change of composition all the
parts like mass mixer cover, shaft blade & joints, surface (inner & outer) etc.
Start
Time
Finish
Time
Total hrs. of
running
Breakdown
Start
End
Down Time
hrs.
Product &
Batch No.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/56 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
SCOPE
5)
PROCEDURE
5.1 Before starting the new product / batch, tablets from the previous product/ batch are
removed from the inspection area.
5.2 All the containers etc. are removed from the inspection area.
5.3 A label having details about product Batch no. of the new product to be inspected is
affixed on the table at which the inspection is done.
5.4 Checker for the inspection of the tablets are changed after every four hours.
5.5 Clean cotton gloves are used for inspection of tablets, gloves are changed after every
four hours.
5.6 Proper record are maintained of rejected tablets and type of rejection found as per
SOP.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
Ensure that all the compressed tablets of the previous product / batch have
been removed.
2)
With the help of a vacuum cleaner remove all the dust accumulated on the
floor, walls and the exterior surface of the machine
3)
Clean all the SS plates as well as the floor with the help of a wet mop.
4)
All the accessories of the DT apparatus and weighing balance are properly
cleaned before commencing compression of the next product / batch.
5)
Inspect the empty aluminium / plastic containers and the polythene bags
designated for the product to be compressed, for proper cleanliness and for the
label having details about Product Batch No. and Serial No. of containers etc.
6)
Ensure that the compression operator wears proper hand gloves, cap and
mask.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
Ensure proper line clearance before starting packing operation for the next
product / batch.
5.1.2
5.1.3
All the packing material and the bulk tablets are stored in such a way that
the product identification is easy and movements of these materials do not
lead to accident and hindrance to the movement of personnel.
5.1.4
With help of vacuum cleaner, all the dust on the floor as well as walls and
exterior of strip/ blister-packing machine is be removed periodically.
5.1.5
All employees working in the packing area wore clean uniforms. Operator
responsible for running the strip-packing machine wore hand gloves and
face mask.
5.1.6
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1 As soon as the manufacturing of the previous product over, disassemble the following
parts:a)
b)
c)
d)
e)
f)
5.2 Connect the bottom discharge valve to the draining with the help of PVC pipe used
for draining out the washing.
5.4 Now pass steam for 5 minutes through the steam inlet to melt wax contents.
5.5 Drain out melted waxy contents through the bottom discharge valve.
5.7 Raise the hood and clean interior of the hood and the bowl.
Sign...
5.10
Rinse the interior of compounding vessel with hot tap water and then
subsequently with D. M. water to remove all the traces of detergent. It is
confirmed by checking the pH of the water.
5.11
Dry the interior and exterior of the compounding vessel with lint free fresh cotton
cloth.
5.12
Sanitize the entire interior surface as well as the contra rotary heater with the help
of 70% I.P.A. and leave it for drying.
5.13
Reassemble the sets and bring down the hood to its lowest position. After
cleaning, the label should stick & mention READY FOR USE.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/60 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
SECTION)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
Wipe the wax contents from the tank with a lint free clean cotton cloth.
5.2
Clean entire exterior and interior with the help of hot Teepol solution (0.1%).
5.3
Rinse with D.M. Water at least thrice to remove the traces of detergent by checking
pH, if detergent is present then rinse with D.M. water again.
5.4
Dry the interior and exterior surface with lint free cloth and after drying sanitize
with 70% IPA and affix an appropriate cleaning label.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1)
Isolate the machine from power and remover hopper along with valve housing.
5.2)
5.3)
5.4)
Check the jaws of the first fold, second fold and embossing and clean with hot
Teepol solution (0.1%) and then with plain hot water.
5.5)
The hopper valve housing nozzle release pin, and cap holders are first washed
with hot Teepol solution (0.1%). Then use plain hot water at least twice to remove
the detergent and dried with lint free cloth.
5.6)
Overall, clean the outside of the machine with hot Teepol solution (0.1%) and
rinse twice with plain hot water and dry with lint free wet cloth. If there is any
sign of the presence of cream / ointment, repeat the cleaning process. Now
sanitize all the parts coming in contact with product with 70% I.P.A.
5.7)
Now reassemble valve housing nozzle and hopper, place the caps back in the belt
and the fix the outlet can suitably.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/62 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
SCOPE
5)
PROCEDURE
2)
3)
Dedust external surface with vacuum cleaner and then clean properly with
lint free cloth duster. Use clean towel and cotton gloves.
4)
5)
After polishing keep polished capsule in cleaned, moisture and light free air
tight containers.
6)
Separate polishing cloth from polishing chamber and replace it with a fresh
polishing cloth. Record is maintained in the format.
TITLE: SOP FOR CLEANING OF S.S. WAX MELTING VESSEL Page : 01-01
(TOPICAL SECTION)
Deptt.: PRODUCTION
SOP No.: SPD/63 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1 When the oil phase is transferred compounding vessel, fill the tank with hot tap water
(60OC) and clean inner surface with the help of nylon cloth brush. Again fill the
tank up to 90% water of its capacity and steam is passed until the temperature set
to 90OC. So that wax melts and get mixed with hot water and drains it. Again fill
the tank with (0.1% Teepol solution) and heated to 90 OC. Leave for 20 minutes
and drawn off from the mixture and run the tank with plain hot water at least
thrice to remove detergent.
5.2 Take 0.01% NaOH and rub the inner surface of the tank to remove any trace of wax.
5.3 Rinse tank with plain hot water and repeat the process three times, to remove trace of
alkali and checked by using pH paper.
5.4 Clean the interior of the tank with freshly D.M. water collected.
5.5 Finally clean the lid and place it over the tank and label READY FOR USE it.
TITLE: SOP FOR FOR POLISHING OF PUNCHES AND DIES
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/64 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
SCOPE
5)
PROCEDURE
A.
B.
2.
3.
4.
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/64 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
C.
Sign...
Recommended Tools and Compounds:1. Magnifying glass, for identifying the damaged surface and finished of the tip.
2. Nylon brush, (cup type) with emery paste, for cleaning and polishing of punch
tip.
3. Oil-stone and lapping stick, for removing the burr or claw.
4. Felt-bob, with emery paste, for polishing the die-bore.
5. Emery paper 150 grit, for removing corrosion from the tools.
6. Diamond past (3 micron) for removing continuous sticking.
7. Silicon paste or luster bar or emery flour, for improving the surface finish.
8. Nylon brush, (wheel type) for polishing embossed tips.
E.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
After using scrapper and utensils, clean all utensils and remove the wax material.
5.2
5.3
5.4
Clean all the area like grooves and sharp angle with tiny Nylon brush to remove the
left over.
5.5
5.6
5.7
5.8
TITLE: SOP FOR REMOVAL OF BULK FROM TUBE FILLING Page : 01-01
MACHINE (TOPICAL SECTION)
Deptt.: PRODUCTION
SOP No.: SPD/66 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1 Finished material leaked from side and back side of the valve connected in a S.S.
container and labeled as Container For Rejection.
5.2 This amount is converted into equivalent number of filled tubes utilized for
reconciliation.
5.3 Such leaked semisolid is disposed off after filling operation for each batch.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
pH Checking.
5.2
5.3
While the tube filling operation is on, weight of net filled quantity per tube is
checked at the interval of 30 minutes by the I.P., Q/C. by checking the weight of
empty tubes and gross weight.
5.4
I.P., Q/C. should check the crimping, coding of the filled Aluminum collapsible
tube or plastic tube take and the embossing of Batch number and manufacturing
date at the interval of 30 minutes. Quality for embossing is controlled by adjusting
pressure excreted by jaws, to prevent pinhole developments on the embossed
letter.
5.5
ii.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/68 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
i.
ii.
iii.
Equipment and accessories not in use are properly covered and labeled.
iv.
All employees wore neat & clean uniform, footwear & Surgeons cap and mouth
cover.
v.
At suitable interval the floor is cleaned, to clear any spoilage from floor.
vi.
The accessories i.e. scoops, spatulas, though in continuous use are nevertheless be
adequately covered with polythene sheets and kept at a pre-designated place.
vii.
The operator wore rubber / plastic/ disposable hand gloves, facemask, and as per
required.
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/69 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
SCOPE
5)
PROCEDURE
5.1 Before setting of compression machine, immerse all new punches and dies (including
extra sets) into sufficient quantity of diesel for 30 minutes.
5.2 Wipe all punches and dies with cotton rags to remove any traces of grease.
5.3 Discard diesel after use, clean the tray of diesel to ensure the absence of any
particulate matter from diesel and punch sets.
5.4 Immerse all punches and dies into fresh diesel (sufficient) for 10 minutes and then
wipe with cotton rags.
5.5 Check any 2 dies by dipping in fresh clear diesel to confirm the absence any
particulate matter.
5.6 Issue the required no. of punches and dies for setting on compression machine and
keep remaining extra sets in respective box after oiling.
TITLE: SOP FOR INSTALLATION OF NEW PUNCH SET
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/69 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
Sign...
Wipe required no. of punches and dies with duster dipped in clear diesel.
b)
2)
3)
After visual inspection of punch tip and die bore, start setting as per SOP.
Immerse all punches and dies into sufficient diesel for minimum 30
minute.
2)
Wipe all punches, dies & dies bore with cotton rags and make respective
entries in punch stock record.
3)
Apply a thin layer of oil (SAE 40) on punch tip, body head & die bore,
after inspecting them in absence of previous material and any damage to
punch set.
4)
Keep punches and dies in respective punch boxes in spare part room.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
5.2
5.3
5.4
5.5
5.6
5.7
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/71 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1 The packing line should be free from filled product and packing material of previous
batch i.e. overprinted carton, rejected tubes, shipper.
5.2 On line rejection are removed.
5.3 Any spoilage is moped & cleaned.
5.4 Packing equipment is properly cleaned.
5.5 If packing machine is not used for one week, it should be re-inspected and if required
re-cleaned.
5.6 If above condition is OK, It means line is clear and signed by concerned Q.A.
Manager.
5.7 Packing should not commence, until line clearance is endorsed by Q.A. Manager.
5.8 Line clearance is recorded on a suitable FORMAT.
Page : 01-01
(TOPICAL SECTION)
Deptt.: PRODUCTION
SOP No.: SPD/72 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1 When the water phase is transferred to compounding vessel, fill the tank with hot tap
water (60OC) and clean inner surface with the help of nylon cloth brush. Again fill
the tank up to 90% water of its capacity and steam is passed till the temperature
set to 90OC drain it. Again fill the tank with (0.1% Teepol solution) and heated to
90OC. Leave for 20 minutes and drawn off from the mixture & run the tank with
plain hot water at least thrice to remove detergent.
5.2 Take 0.01% NaOH & rub the inner surface of the tank to remove any trace of wax.
5.3 Rinse tank with plain hot water and repeat the process three times, to remove trace of
alkali and checked by using pH paper.
5.4 Clean the interior of the tank with freshly D.M. water collected.
5.5 Finally clean the lid and place it over the tank and label it.
TITLE: SOP FOR IN PROCESS FILL WEIGHT
Page : 01-01
DETERMINATION
Deptt.: PRODUCTION
SOP No.: SPD/73 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
A)
B)
C)
2.
Minimum and Maximum limits for fill weight is established & recorded
on the in process sheet.
3.
2.
During filling:
1.
2.
Fill and record the individual gross, tare & net weights.
3.
Compare net filled weight, obtained net weight to determine average fill
weight.
The average net weight is not less than the labeled amount and the net weight of any single
container is between 91% to 109% for 5gm to 50gm tubes and between 95.5% to 104.5% for 50
gm to 100gm.
TITLE: SOP FOR LABELING & PACKING OF ORAL LIQUID Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/74 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1
5.2
Check the overprinting details i.e. Batch No, Mfg. Date, Exp. Date and M.R.P. etc.
and tick mark after checking of correctness of overprinting matter enter these data
in logbook & get it verified.
5.3
Paste samples of overprinted label and carton, sign. on them and get certified from
QA.
5.4
5.5
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1.
The General Utensils like S.S. Container, S.S. Scoops; S.S. Trays etc. are washed
with water.
5.2.
Wash with liquid soap or detergent with gentle rubbing then again wash with
fresh water until the detergent foam is completely washed out.
5.3.
Finally washed with DM Water and are checked from the Q.C. Lab.
5.4.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
Sign...
SCOPE
5)
PROCEDURE
5.1 Doors, windows and portion are de-dusted once in the evening after the days work is
over. The dust is collected in a closed dustbin.
5.2 Floors of mining blending, tableting, coating & capsule filling etc. areas are de-dusted
in the evening after the days work and the dusts are collected in the dust bin.
5.3 Similarly all the hoopers & extensors machines, tables and other furniture and
fixtures are de-dusted and the resulting dust is collected in the same dustbin.
5.4 The entire collected dust is dumped in the pit meant for disposal of sensitizing
material
5.5 The entire area including windows, doors, table hoops etc. are then moped by using
Non Ionic soap:a)
b)
Formula:
c)
Process water
d)
20 gm
10 Liters
5.6 The floor of working area is de-dusted with broom slice and moped with detergent
solution just before the start of days work.
5.7 The machine interiors are not required to be wet moped.
Sign...
5.8
The moping dish should be strained in the bucket and then dried.
5.9
The remnant of the moping solution is put in the mainhole where the wash
water effluent from hormone/ -Lactum section is coming.
The walls of the rooms are painted once a year using alkaline/neutral epoxy
bound distemper.
5.11
5.12
5.13
Sign...
CLEANING RECORD FOR TABLET, CAPSULE & DRY SYRUP MANUFACTURING SECTION
S. No.
Area
Floors
Platform
Walls
Doors/
Windows
Ceilings
Exhaust fan
Ceiling Fan
Tube lights
Done by
Chec
ked
by
Washing using
scrubber and
hose of water,
damp mop with
disinfectant
Twice a day
Vacuum
cleaning
Cleaning with
0.1% solution of
detergent with
moping
Daily
Monthly
Vaccum of
Vaccum of
Cleaning moping Cleaning moping
with 0.1% detergent
with 0.1%
solution
detergent
solution
Vaccum of
Cleaning
moping with
0.1% detergent
solution
Weekly
Once a day
Weekly
Weekly
Cleaning Schedule:
S. No.
Area Name
Cleaning Schedule
1.
Floors
Twice a day
2.
3.
Walls
Twice a week
Doors / Windows
Daily
5.
Ceilings
Monthly
6.
Exhaust Fan
Weekly
7.
Ceiling Fan
Weekly
8.
Tube Lights
Weekly
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
PROCEDURE
5.1
Transfer the tank, containers with its lid, membrane filter holder and pressure
vessels to the washing area.
5.2
Keep aside the lid and other part of vessels at sufficient height.
5.3
Flush the tank and vessel with D.M. Water. Scrub with 0.1% Teepol solution
using nylon ball. Wash the lid similarly.
5.4
5.5
Rinse with filtered Distilled water, and drain off completely. Fix the lid properly.
5.6
5.7
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/78 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1.
5.2.
5.3.
Check oil in the gearbox and wipe the excess of oil using cotton waste.
5.4.
Wipe the surfaces of conveyor belt and table, using clean dry cloth. Use vacuum
cleaner, if required.
5.5.
Moping the surfaces of tabletop and conveyor belt using, 0.5% solution of Teepol.
Remove any stains or pieces of gum tape sticked on the surfaces, using clean
cloth. Again moping the surfaces repeatedly, using clean cloth dipped in water.
Ensure complete removal of detergent. Wipe dry the surfaces using clean dry
cloth.
5.6.
Switch on the machine and bring the lower portion of conveyor belt, on the top to
facilitate cleaning.
5.7.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
The entire Machine Operation & Cleaning procedure is divided in three stages.
i)
ii)
Operation
iii)
STAGE I
a)
b)
The electrical connections are restored by pulling the plug top into the
socket.
c)
d)
The filling syringe inlet pipe fitted with the filling machine is cleaned by
D.M. water.
e)
STAGE II
a)
The Bottle Filling Machine is switched on and run for few seconds to
observe whether it is running normally or not.
b)
c)
In other case, the machine is started and the liquid is out from the syringe
and the volume set as required.
d)
STAGE III
a)
b)
Once the wash water analysis is cleared by Q.C.D. The contact parts and
other parts are moped and dried.
c)
The connection is then cut off by taking out the plug top from the socket.
d)
A logbook is kept for each machine of operation in the format given in annexure 1
ANNEXURE-I
LOG BOOK
Start
Time
Finish
Time
Total hrs. of
running
Machine No.
Breakdown
Start
End
Down
Time
hrs.
Page No.____
Product,
Batch No.,
B. Size, Mfd.
& Exp.
Operator
&
Checked
By
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
STAGE I
a)
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
The Machine Ready for use sticker is removed and sticker/tag showing product
Batch No. etc. is put on the top cover of the machine.
d)
Connect the jet with D. M. Water and check the pressure of the water flow.
STAGE II
a)
The Bottle Washing Machine is switched on and run for few seconds to observe
whether it is running normally or not.
b)
If any abnormal sound is heard the machine is referred to maintenance dept. for
rectification.
c)
In other case the machine is started and the bottle wash with the help of brush.
d)
The brushed bottle is dipped into fresh D. M. Water and then these bottle washed
with the jet.
e)
STAGE III
a)
After the days operation or production change or change of composition all the
contact parts like brush and containers etc. are thoroughly cleaned by detergent
potable water and finally by D. M. Water.
b)
Once the wash water analysis is cleared by Q.C.D. The contact parts and other
parts are moped and dried.
c)
The connection is then cut off by taking out the plug top from the socket.
d)
A logbook is kept for each machine of operation in the format given in annexure 1
ANNEXURE-I
LOG BOOK
Date
Start
Time
Finish
Time
Total hrs. of
running
Breakdown
Start
End
Machine No.
Down
Time
hrs.
Product,
Batch No.,
B. Size, Mfd.
& Exp.
Page No._
Operator
&
Checked
By
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
ii)
Operation
iii)
STAGE I
a.
b.
The electrical connections are restored by pulling the plug top into the socket.
c.
d.
e.
STAGE II
a.
The colloidal mill is switched on and run for few seconds to observe whether if is
running normally or not.
b.
If any abnormal sound is heard the machine is referred to maintenance dept. for
rectification.
c.
In other case the machine is started and the liquid is out on the hopper slowly and
gradually.
d.
e.
f.
In case of batch changes, the contact parts are cleaned by water and then D.M.
water.
STAGE III
a.
After the days operation or Production change or change of composition all the
contact parts like hopper, pipe and grinding parts are thoroughly cleaned and
wash water is sent to Q.C.D. for testing.
b.
Once the wash water analysis is cleared by Q.C.D. The contact parts and other
parts are moped and dried.
c.
The connection is then cut off by taking out the plug top from the socket.
d.
A sticker stating MACHINE READY FOR USE is put on the machine to render
it ready for use.
A logbook is kept for each machine of operation in the format given in annexure 1
TITLE: SOP FOR OPERATION & CLEANING OF COLLOIDAL Page : 03-03
MACHINE
Deptt.: PRODUCTION
SOP No.: SPD/81 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
ANNEXURE-I
LOG BOOK
Start
Time
Finish
Time
Total hrs. of
running
Machine No.
Breakdown
Start
End
Page No.____
Down
Time
hrs.
Product,
Batch No.,
B. Size, Mfd.
& Exp.
Operator
&
Checked
By
TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 01-03
STIRRER
Deptt.: PRODUCTION
SOP No.: SPD/82 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
6.2
Operation
STAGE I
a.
b.
The electrical connections are restored by pulling the plug top into the socket.
c.
d.
The S.S. Drum 1000 or 500 Lts. fitted with stirrer. Stirring rod fitted with stirrer
and solution kept into S.S. Drum.
TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 02-03
STIRRER
Deptt.: PRODUCTION
SOP No.: SPD/82 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
STAGE II
a.
The High Speed Stirrer is switched on and run for few seconds to observe whether
it is running normally or not.
b.
If any abnormal sound is heard, the machine is referred to maintenance dept. for
rectification.
c.
d.
e.
In case of batch changes, the contact parts are cleaned with water.
f.
In case of Product or composition change, the entire machine is washed and wash
water analysis is to be done to by Q.C.D. render the machine ready for further
use.
After the days operation or Production change or change of composition all the
contact parts like mixing blade & shaft are thoroughly cleaned and washed. Final
washing to be done by D.M water and wash water is sent to Q.C.D. for testing.
b.
Once the wash water analysis is cleared by Q.C.D. The Mass Mixer surface (inner
& outer), cover, blade shaft etc. are moped and dried.
c.
The connection is then cut off by taking out the plug top from the socket.
d.
TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 03-03
STIRRER
Deptt.: PRODUCTION
SOP No.: SPD/82 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
A logbook is kept for each machine of operation in the format given in annexure 1
ANNEXURE-I
LOG BOOK
M/C: HIGH SPEED STIRRER
Date
Start
Time
Finish
Time
Total hrs. of
running
Machine No.
Breakdown
Start
End
Page No.____
Down
Time
hrs.
Product,
Batch No.,
B. Size, Mfd.
& Exp.
Operator
&
Checked
By
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
Operation
6.3
STAGE I
a)
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
d)
The inlet pipe is connected with filtering liquid and outlet pipe with reservoir
tank.
e)
f)
The container containing the filter liquid brought near the machine.
STAGE II
a)
The Filter Press is switched on and run for few seconds to observe whether if is
running normally or not.
b)
If any abnormal sound is heard the machine is referred to maintenance dept. for
rectification.
c)
In other case the machine is started and the liquid is out throw out let pipe slowly
and gradually.
d)
e)
f)
In case of batch changes, the contact parts are cleaned by D.M water and wash
water analysis is to be done by Q.C.D. render the machine ready for the use.
STAGE III
a)
After the days operation or Production change or change of composition all the
contact parts like filter pads, pipe and filter assembly etc. are thoroughly cleaned
and wash water is sent to Q.C.D. for testing.
b)
Once the wash water analysis is cleared by Q.C.D. The contact parts and other
parts are moped and dried.
c)
The connection is then cut off by taking out the plug top from the socket.
d)
ANNEXURE-I
LOG BOOK
Machine Name: Filter Press
Date
Start
Time
Finish
Time
Total hrs. of
running
Breakdown
Start
End
Down
Time
hrs.
Page No.____
Product,
Batch No.,
B. Size, Mfd.
& Exp.
Operator
&
Checked
By
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
MACHINE NAME :
6.2
Operation
STAGE I
a)
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
d)
Bottle guides to adjust sealing machine according to the size of the bottle.
e)
The machine shifted near the filling machine for easy handling of the bottle.
STAGE II
a)
The P. P.Cap sealing Machine is switched on and run for few seconds to observe
whether it is running normally or not.
b)
If any abnormal sound is heard the machine is referred to maintenance dept. for
rectification.
c)
In other case the machine is started and check the sealing and threading of the P.
P. Caps.
d)
e)
a)
After the days operation or Production change or change of composition all the
contact parts like rubber pad and sealing head etc. are thoroughly cleaned with
water and moped with dry cloth.
b)
The connection is then cut off by taking out the plug top from the socket.
c)
Start
Time
Finish
Time
Total hrs. of
running
Machine No.
Breakdown
Start
End
Down
Time hrs.
Page No.____
Product,
Batch No.,
B. Size, Mfd.
& Exp.
Operator
&
Checked
By
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/85 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1.
Inspection of filled unit in front of illuminated light for following type of foreign
particle:
a.
c.
d.
e.
5.2
After checking of these particle on inspection board unit are to be sent for
labeling & packing after getting O.K. report from Q.C. Dept.
5.3
5.4
5.5
5.6
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/85 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
Mfg Date.:
Batch No.:
Exp. Date:
Damage
seal
% of
Rejection
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1.
5.2.
Flush the tank and stirrer with D.M. Water. Scrub with 0.1% Teepol solution
using nylon brush. Wash the lid similarly.
5.4.
5.5.
Again rinse with D.M. water and drain off completely. Fix the lid properly.
5.6.
5.7.
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/87 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1)
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1.
Take the active & non-active contents on per product requirement mention in
R.M. Requisition.
5.2.
Before starting, ensure that the every bag is properly tagged from store
department.
5.4.
5.5.
5.6.
5.7.
Transfer the materials in mass mixer for dry mixing as mention in master formula.
5.8.
5.9.
5.10.
Add the binder in mass mixer & rotate as the dens mass is formed.
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/87 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
5.11.
5.12.
Dry the granules in FBD as the temperature & time mention in master formula.
5.13.
When the moisture content is below 2% unload the granule & add lubricants in
granules as mention in master formula.
5.14.
Transfer the granules in drums & check the wt. & drop the job card in drum.
5.15.
5.16.
After getting the Q.C. report OK. Send the granules for compression.
5.17.
Before starting the compression ensure the cleaning & wash water analysis report.
5.18.
Start the compression & check the hardness & wt. variation of tablet.
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/88 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1.
5.2.
5.3.
5.4.
Check the stripping quality with respect of cutting. It should be sharp & straight.
5.6.
Check the printing quality of B.No, Mfg. Date, Exp. Date & MRP. The ink
should not be spread on the strips.
5.7.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
Check the Equipment Usage and Cleaning Log and ensure that equipment
cleaning operation has been recorded.
5.1.2
5.1.3
If the conditions are not within the limit, do not start the operation and
inform to the Engineering department.
5.1.5
If the conditions are within the limit, then start the operation.
5.1.6
Ensure that the dies punches fitted in the machine are as per the product
specification in the Batch Manufacturing Record.
5.1.7
Check that punches are free in punch guide and upper punches dropped
under their own weight.
5.1.8
5.1.9
Turn the hand wheel in clockwise direction for two to three rotations.
Ensure that turret rotates smoothly.
OPERATION:
5.2.1
5.2.3
5.2.4
5.2.5
5.2.6
5.2.7
5.2.9
5.2.10 Check the tablets for weight variation, thickness, hardness, friability,
disintegration time and other parameters as specified in Batch
Manufacturing Record.
5.2.11 Adjust the parameters to the desired specifications as specified in Batch
Manufacturing Record.
5.2.12 After achieving desired parameters, stop the machine.
5.2.13 Inform In-process quality assurance officer to collect the sample for
dissolution test, if required or as specified in Batch Manufacturing Record.
5.2.14 Remove the high-density polyethylene container in which the tablets are
collected and keep it aside on the container trolly.
5.2.15 Replace the CONTAINER STATUS label of
polyethylene container with RECOVERABLES label.
high-density
5.2.16 Tear off the CONTAINER STATUS label after confirming the details
on it and put it in the waste bin.
SHUT DOWN
5.3.1
5.3.2
5.3.3
5.3.4
5.3.6
Remove the status label from the equipment, tear it off, and put in the
waste bin.
5.3.7
CLEANING:
5.4.1
5.4.2
5.4.1.2
5.4.1.3
5.4.1.4
5.4.1.5
5.4.2.2
5.4.2.3
Lubricate the dies and punches with food grade oil and transfer
to the respective place.
5.4.2.5
Clean the parts with raw water and ensure that the parts are
visually clean.
5.4.2.6
Clean the parts with 0.1 % w/v of Teepol solution & flush with
plenty of raw water to remove traces of Teepol solution.
5.4.2.7
Clean the machine body using lint free cloth dipped in potable
water followed by dry lint free cloth.
5.4.2.9
5.4.2.10
5.4.2.11
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
Check the Equipment Usage and Cleaning Log and ensure that equipmentcleaning operation has been recorded.
5.1.2
5.1.3
5.1.4
If the conditions are not within the limit, do not start the operation and
inform to the Engineering department.
5.1.5
If the conditions are within the limit, then start the operation.
Ensure that the dies punches fitted in the machine are as per the product
specification in the Batch Manufacturing Record.
5.1.7
Check that punches are free in punch guide and upper punches dropped
under their own weight.
5.1.8
5.1.9
Turn the hand wheel in clockwise direction for two to three rotations.
Ensure that turret rotates smoothly.
5.2.2
5.2.3
5.2.5
5.2.6
5.2.7
5.2.9
5.2.10 Check the tablets for weight variation, thickness, hardness, friability,
disintegration time and other parameters as specified in Batch
Manufacturing Record.
5.2.11 Adjust the parameters to the desired specifications as specified in Batch
Manufacturing Record.
5.2.12 After achieving desired parameters, stop the machine.
5.2.13 Inform In-process quality assurance officer to collect the sample for
dissolution test, if required or as specified in Batch Manufacturing Record.
5.2.14 Remove the high-density polyethylene container in which the tablets are
collected and keep it aside on the container trolley.
5.2.15 Replace the CONTAINER STATUS label of
polyethylene container with RECOVERABLES label.
high-density
5.2.16 Tear off the CONTAINER STATUS label after confirming the details
on it and put it in the waste bin.
5.2.17 Place the Tablet De-duster exactly below the discharge chute of
compression machine.
5.3.2
5.3.3
5.3.4
5.3.5
Remove the status label from the equipment, tear it off, and put in the
dustbin.
5.3.7
CLEANING:
5.4.1
5.4.1.2
5.4.1.3
5.4.1.4
5.4.1.5
5.4.2
5.4.2.3
Lubricate the dies and punches with food grade oil and
transfer to the respective place.
5.4.2.4
Clean the parts with raw water and ensure that the parts are
visually clean.
5.4.2.6
Clean the parts with 0.1 % w/v of Teepol solution & flush
with plenty of raw water to remove traces of Teepol
solution.
5.4.2.7
5.4.2.9
5.4.2.10
5.4.2.11
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
Cleaning:-
1.
Dismantle the hopper & filling nozzle & clean it throughly with jet of
water. Use 0.2% teepol solution to remove the deposited medicine.
2.
Rinse twice with tap water followed by twice with purified water IP.
3.
Clean machine body & other parts of the machine, (which cannot be
detached) with a wet cloth followed by a dry cloth.
4.
OPERATION:1.
3.
Tube Filling: - Load clean tubes in the filling trays fill the hopper of filling
machine with product and cover it. Fit filling nozzle of appropriate size, set fill
weight as per requirement. Run the machine for 2 minutes but do not fill the
product in the tubes. After 2 minutes, check average weight per stroke .Adjust if
necessary.
B)
Crimping :- Crimp each tube , check the finishing of crimped tubes regularly
& also ensure that tubes don't get pressurized during crimping.
C)
Batch Coding: - Set the batch No, print it on the tube and cross check with the
B.P.R . The print must be clear.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
Introduction: The base of the cream and ointments is generally petroleum. Paint is
soluble in petroleum bases. During filling and other process of mfg., some amount of
cream sticks to the outer surfaces of tubes. If this cream is not removed early, the paint on
the outer side of the tube may come off. It is therefore necessary to clean the tube as early
as possible after filling.
CLEANING & INSPECTION: - Inspect each filled tube individually. Reject the tube
with following characteristics:
1.
2.
Tube is punctured.
3.
4.
5.
6.
Collapsed tubes.
and GREEN
PROCEDURE: Take a damp cloth & clean the tube surface followed by cleaning
with a dry cloth. Check that tubes paint & printing is not damaged during cleaning. Pack
the tube in the unit carton or as described in this master formula.
TITLE: SOP FOR BATCH DESTRUCTION
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/93 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
(A)
(B)
PARENTERAL SECTION:
1.
2.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
2.
Assemble the stirrer blade inside the tank and place items to be mixed in the tank
3.
Raise the tank by moving the handle clockwise to fit the tank on the lid .
4.
Switch on motor by pressing green button on the starter. Now motor is in neutral
gear. Shift the gear as the speed required i.e. first gear, IInd gear or IIIrd gear.
6.
Switch off the stirrer when mixing is complete by pushing red button on the
starter.
7.
Bring the tank down by rotating the handle anticlockwise. Remove tank & stirrer
blade from the stand and cover them.
2.
3.
4.
Procedure:
1.
Hose down sides of the tank, stirrer shaft & blades and lid of the tank with tap
water. Drain the water.
2.
Scrub tank, shaft blades etc with teepol solution & brush. Use hot water to remove
deposited material.
3.
4.
Drain the water & rinse tank with D.M. water I.P. and ask Q.C.Deptt to withdraw
sample of wash water and give test report.
5.
6.
7.
Put CLEAN equipment tag on the mixer when lab approves the wash water.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
CLEANING:-
1.
Detach hopper and wash with 0.2% teepol solution rinse with several washes of
water. Fit it back to its position.
2.
Fill water in hopper & operate the machine so that medicine in the grinding slit is
also removed .Drain the water.
3.
Take hot water & repeat the above process. Drain the water.
4.
Take purified water IP in the hopper & run the machine for 2 minutes. Drain the
water.
5.
Refill purified water IP in the hopper & run the machine for 2 minutes .Request
Q.C Deptt. to withdraw sample of wash water.
6.
Put clean equipment tag in the machine after getting approval from Q.C Dept.
OPERATION:1.
2.
In case the mill stops abruptly switch it off. Enlarge the grinding slit & restart.
4.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
Wash down sides of the tank, stirrer shaft & blades and lid of the tank with tap
water. Drain the water.
5.2
Scrub tank, shaft blades etc with teepol solution & brush. Use hot water to remove
deposited material.
5.3
5.4
Drain the water & rinse tank with purified water I.P. and ask Q.C.Deptt to
withdraw sample of wash water and give test report.
5.5
5.6
Put clean equipment tag on the mixer when lab approves the wash water.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
1.)
Cream
2.)
Ointment
3.)
1.1.2
1.1.3
Add any raw material to above phases as per direction given in MFR.
1.1.4
1.1.5
1.1.6
Switch on planetary mixer & continue till cream formation tanks place.
This will take 6-7 hours in summer & 3-4 hours in winter.
1.1.7
1.1.8
After all the ingredients has been added & weight of batch has been made
upto mark switch on shrives & continue for minimum one hour.
1.1.10 Pass the batch through colloid mill, send sample for bulk analysis.
TITLE: SOP FOR BATCH PREPARATION OF EXTERNAL
Page : 02-02
PREPARATION
Deptt.: PRODUCTION
SOP No.: SPD/97 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1.2
PROCEDURE FOR OINTMENT:As the Ointment generally do not contain water. Protect the batch from water. Use
dry equipment only.
5.3
A.
B.
C.
D.
A.
B.
C.
PURPOSE
2)
RESPONSIBILITY
3)
ACCOUNTABILITY :
4)
SCOPE
5)
REQUIREMENTS
6.
5.1
5.2
Scrubbing brush.
5.3
Potable water
5.4
Purified water
5.5
5.6
6.4 INITIAL RINSE: - Rinse with potable water until they are free from teepol.
6.5 FINAL RINSE: - Rinse all washed articles twice each with purified water followed
by
water for injection.
6.6 WASH WATER ANALYSIS: - Request Q.C. Dept to withdraw sample of wash
water & send their results for the testing of detergent & last batch traces. Put
clean equipment tag after getting approval from Q.C Dept.
7.
Page : 01-02
Deptt.: PRODUCTION
SOP No.: SPD/99 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
1.
PURPOSE
2.
RESPONSIBILITY
Q/C Manager.
3.
ACCOUNTABILITY :
4.
SCOPE
5.
PROCEDURE:
M/C No.:
Coating Pan
2)
Exhaust System
3)
Ensure the working and effectiveness of exhaust system and the hot air
blower.
b)
c)
Carry out coating operation as per the standard procedure laid down in the
product BMR. Following parameters must be strictly adhered to:
1)
2)
3)
Excaust System
5)
Spray pattern
Page : 02-02
Deptt.: PRODUCTION
SOP No.: SPD/99 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign.. Sign.. Sign....... Sign...
d)
e)
Remove the coated tablets from the pan into double poly bags in
aluminium containers properly labelled.
DISMANTLING:-
1)
2)
b)
Exhaust system
c)
Coating Pan
Remove:a)
b)
Exhaust Pipes
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1 Finished formulations are kept in quarantine stores till it is cleared by Q.C.D.
5.2 Once cleared by Q.C.D. They are packed in strips/blister strip/bottles/jars etc. as per
the individual case.
5.3 Once the product is packed they are transferred to commercial store vide the transfer
note as per the following format:
Q.C. Deptt.
Q.A. Deptt.
Sign...
5.4 Once the Product is transferred they are kept Product-wise with separate identity
Slip/BIN Card attached.
5.5 Production dept. maintains a register indicating daily transfer details in the following
format:
Date
Product
Batch
No.
Units
Transferred
No. of
cases
Sent by
Received
by
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
Operation
5.3
STAGE I
a) The electrical connections are restored by pulling the plug top into the socket.
b) The exterior of the machine is cleaned with dry cloth.
c) The MACHINE READY FOR USE Sticker is removed and sticker/tag
showing product, Batch No. etc. is put on the top cover of the machine.
d) Arrange a polythene bag kept in a plastic drum for storage of dried
granules/material.
STAGE II
a) The machine is switched on and run for few seconds to observe whether it is
running normally or not.
b) If any abnormal sound is heard the machine is referred to maintenance deptt. for
rectification.
c) Put the granule & powder in the trays & kept for drying.
Sign...
d) Then set the required temperature & drying time for 30 minutes & start the
machine.
e) After 30 minutes stop the machine & manipulate the material of trays.
f) Again start the machine check the granules in between.
g) Check the moisture content of granules if found under the limit, stop the drying.
If not, continue the drying till the required moisture content is obtained
collect the granules in a plastic bag in a fiber drum.
h) The process is continued till the entire granules are dried.
i) In case of batch change the contact parts are cleaned with dry clothes.
j) Once the process is over put the sticker starting to be cleaned on the machine.
k) In case of product or composition change the entire machine is washed and wash
water analysis is to be done to by Q.C.D. render the machine is ready for
further use.
STAGE III
a) The connection is cut off by taking out the plug to from the socket.
b) After the days operation a product change or change of composition the sticker
starting to be cleaned is removed.
c) The trays are thoroughly washed with the help of detergent & wash with water
till the to am is washed out then wash with D.M. Water.
d) Once the wash water analysis is cleared by Q.C.D. set the machine. Below the
F.B.D. A sticker starting MACHINE READY FOR USE in put on the
machine to render it ready for use.
Page : 03-03
Sign...
Page No.:.......
Machine/Equipment Code:
Location:.........
Date
Start
Time
Finish
Time
Total Hours
of Running
Break Down
START END
Down Time
Hours
Production/
Batch No.
Operated
By
Checked
By
Page : 01-03
Deptt.: PRODUCTION
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
OPERATION
5.1
5.2
5.3
Load the base material on to the base material reel feed shaft.
5.4
Maintain the distance of approx. 150 mm from the machine body surface to the
center of the reel.
5.5
Load the lidding foil on the lidding foil red feed shaft.
5.6
Check the set the temperature of the pre-heater top heater top platen, bottom
platen and sealing heater according to the base material and lidding material on
the MMI.
5.7
Manually switch OFF the pneumatically operated basic valve lever to pinch
roller that is located on the indexing unit.
5.8
Then pass the base film to the indexing unit through pre heater platen in
between the top platen and bottom platen through dancing arm and guide rollers
to the sealing station though the forming die and blow head of forming station
pass over the web guide track.
5.9
On the MMI (Man Machine Interface) recalled the program for particular
formatting by switch ON control panel and scrolling the MMI screen by
entering the multiple level of password.
Page : 02-03
Deptt.: PRODUCTION
Sign...
5.10
Enter all the information in the formatting part according to the product.
5.11
5.12
5.13
5.14
Then switch ON the machine in RUN MODE by pressing the START push
button.
5.15
The machine will form the blister in a continuous web from. Machine run for few
cycles and then switches OFF the machine.
5.16
Check the formed web for consisting of the form of blisters and the quality
parameters of the formed web.
5.17
Drawn the Sealing / Lidding foil to the sealing station over the formed web passes
through the batch code printing station.
5.18
5.19
5.20
Then STOP the machine by pressing red push button and check the sealing
performance.
5.21
Then pass the sealed web to the punching station where the quality blister pack
punches out.
5.22
5.23
RUN the machine in the RUN MODE for few cycles. Then STOP the machine
by pressing red push button and check for the blister pack correctness.
5.24
For any adjustment in sealing station for proper engagement of form blisters to
the sealing die easily by moving the stations horizontally at LHS or RHS at
required position.
Page : 03-03
Deptt.: PRODUCTION
6)
Sign...
5.25
For proper sealing of form blister web to the lidding foil by adjust the pressure
adjustable screws.
5.26
For any adjustment in punching station moving the station horizontally at LHS or
RHS can do according with blister pack that or RHS at require position.
5.27
Then waste web pass over the dancing arm trim winding assembly through the
guide rollers where the waste firm wound over the trim winding shaft.
5.28
When the blister packs meet all the quality parameters then adjust the feeding
system.
5.29
Above all the adjustments have been completed then gradually increase the
machine speed recommended by the instruction manual.
5.30
Load the standard and specified input packing materials means base film and
lidding foil with their specified dimensions and according with the product.
CLEANING PROCEDURE :
6.1
6.2
Clean the hopper foil red feed shaft with distilled water.
6.3
6.4
6.5
Revision No.:
Page : 01-01
Deptt.: PRODUCTION
Review Date: 14-07-2009
Checked By:
Production Manager
Approved By
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
5.1
5.2
Atmospheric air should come through free filter and is stored in receiver
having a safety valve.
5.3
At the pressure of 7 kg or above the main machine releases out the excess air.
5.4
The air is passed through air drier. Firstly the air passed through carbon column
and then silica column.
5.5
Then this air is passed through 0.2 micron in line air filter. Now this sterile air
ready of use in production.
Page : 01-01
Deptt.: PRODUCTION
Review Date: 14-07-2009
Approved By
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
OPERATION
5.1
As the capsule or tablet passes in analysis the material shifted in stripping area.
5.2
5.3
For sterio preparation the B. No., Mfg., Exp. & rates are taken from mfg. record.
5.4
5.5
5.6
Before starting the stripping the line clearance is checked & approval is taken
from Q.A. person.
5.7
Final approval of matter coding on the strip is taken from Q.A. Person.
5.8
5.9
5.10
5.11
Page : 01-01
Deptt.: PRODUCTION
SOP No.: SPD/105 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
OPERATION
5.1
5.2
5.3
5.4
5.5
If there is any leakage it will be accumulated on the sealing side on the cap.
5.6
Page : 01-1
Deptt.: PRODUCTION
SOP No.: SPD/106 Effective Date: 15-07-2007 Revision No.:
Review Date: 14-07-2009
Prepared by:
Checked By:
Approved By
Asstt. Production Chemist
Production Manager
Q.A. Manager
Director
Sign...
1)
PURPOSE
2)
RESPONSIBILITY
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE
5)
PROCEDURE
OPERATION