GMP

(GOOD MANUFACTURING PRACTICES )

What is GMP?
The part of QA ,which make sure that the product are consistently
produced and controlled to the quality standards appropriate to
their intended use and as required by the marketing
authorization.

GMP regulations were introduced in the form of amended

schedule M in 1988. The schedule M has again been amended in a
major way by the Drugs & Cosmetics (8 amendment) Rules ,
th

2001.
Why GMP?

 Provide a high level assurance medicine are manufactured in a

way that ensure their safety , efficacy and quality.

 Medicine are manufactured to comply with their marketing

authorization.

 Quality is built in testing is part of GMP, but alone does not

provide a good level quality assurance.
Principle of GMP

 Manufacturing facilities must maintain a clean and hygenic

manufacturing area .
 Controlled environmental conditions in order to prevent cross
contamination of food or drug product from adulterants that
may render the product unsafe for human consumption .
 Manufacturing process are clearly defined and controlled .All
critical process are validated to ensure consistency and
complains with specifications.
 Manufacturing process are controlled and any changes to the
process are evaluated change that effect the quality of drug are
validated as necessary.
Principle of GMP

 Instructions and procedures are written in clear and

unambiguous language.
 Operators are trained to carry out an document procedures.
 Cross contamination with unlabelled major allergens is
prevented .
What is cGMP?

cGMP refers to the regulations set forth by the US .FDA under

the authority of Federal Food Drug and Cosmetic act. cGMP
regulations require a quality approach to manufacturing
enabling companies to minimize or eliminate
contamination,mixups and errors.
The U.S. GMP regulations are divided
into two parts 210 and 211 , Title 21

 Part 210 ."Current Good Manufacturing Practice in

Manufacturing, Processing, Packaging, or Holding of drugs i.e
provide the framework for the regulations .

 Part 211,"cGMP for Finished Pharmaceuticals,"state the

actual requirements.
Content of part 211of U.S GMP
regulations

 Subpart A General Provision.

 Subpart B Organization and personnel.
 Subpart C Building and facilities.
 Subpart D Equipment.
 Subpart E Control of components and drug product container
and closure
 Subpart F Production and process control.
 Subpart G Packaging and labelling control.
 Subpart H Holding and distribution.
 Subpart I Laboratory control.
 Subpart J Record and reports.
 Subpart K Returned & salvaged drug product.
Comparision of GMP and cGMP
GMP
Quality of drugs is essentially the
responsibility of manufacturers.
GOOD MANUFACTURING
PRACTICES guidelines are a
means to assure this quality of
drugs
cGMP
cGMP refers to the regulations set
forth by the US .FDA under the
authority of Federal Food Drug
and Cosmetic act. cGMP
regulations require a quality
approach to manufacturing
enabling companies to minimize
or eliminate
contamination,mixups and errors.
Why are our SOPs based on cGMP?

cGMP is a good business tool . SOPs based on cGMP

requirements unable the footman company to maintain and
improve complaince , insure consistant quality of the printed
product and maintain our reputation for quality through out
the industry.
GMP For Premises and materials

 GENERAL REQUIREMENTS
 WAREHOUSING AREA
 PRODUCTION AREA
 ANCILLARY AREAS
 QUALITY CONTROL AREA
 PERSONNEL
 HEALTH , CLOTHING AND SANITATION OF
WORKERS
 MANUFACTURING OPERATIONS AND CONTROLS
 SANITATION IN MANUFACTURING PREMISES
 RAW MATERIALS
GMP For Premises and materials

 EQUIPMENT
 DOCUMENTATION AND RECORDS
 LABELS AND OTHER PRINTED MATERIALS
 QUALITY ASSURANCE (QA)
 SELF INSPECTION AND
 QUALITY AUDIT
 QUALITY CONTROL SYSTEM
 SPECIFICATIONS
 MASTER FORMULA RECORD
 BATCH PACKAGING RECORDS
 BATCH PROCESSING RECORDSSTANDARD
OPERATING PROCEDURES ( SOPs) AND
RECORDS
 GMP FOR PREMISES
AND MATERIALS

1. GENERAL REQUIREMENTS
1.1 LOCATION AND SURROUNDINGS –
The location of the factory and it`s surroundings should be
such as to avoid risk of contamination from external environment
including open sewage , drain , public lavatory or any factory which
produces disagreeable or obnxious odour , fumes , excessive soot , dust
, smoke ,
Chemical or biological emissions.

1.2 BUILDINGS AND PREMISES –

They should conform to the conditions laid down in the Factories
Act , 1948 . The buildings used for the factory shall be designed ,
constructed , adapted and maintained to suit the manufacturing
operations so as to permit production of drugs under hygienic
conditions.

The premises used for manufacturing , processing ,

warehousing , packaging , labelling and testing purpose shall be
compatible with other drug manufacturing operations that may be
carried out in the same or adjacent area.
The premises should be so constructed and maintained as to prevent
entry of insects , pests , birds , vermin's and rodents. Interior surface
shall be smooth and free from cracks , and permit easy cleaning ,
painting and disinfection and shall not shed particles.

1.3 WATER SYSTEM –

There shall be validated system for treatment of water so as to
produce purified water conforming to IP specification. Water shall
be stored purified conforming to IP specification. Water shall be
stored in tanks , which don`t adversely affect quality of water an
ensure freedom from microbiological growth. The tanks shall be
cleaned periodically and record maintained by the
Licensee in this behalf. Only purified water shall be used for all the
operations.

1.4 DISPOSAL OF WASTE –

Provisions shall be made for the proper storage and disposal of
materials awaiting disposal. The disposal of sewage and effluents
from the manufactory shall be as required under the environmental
Pollution Control Board whereas all biomedical waste shall be
destroyed as per the provisions of the Biomedical Waste Rules ,
1996.
 2. WAREHOUSING AREA
Adequate areas shall be designed and provided with proper racks ,
bins and platforms for the storage and warehousing of all materials
and products , machine and equipment parts etc. Warehousing
areas shall be designed and adapted to ensure good storage
conditions . They shall be clean, dry and maintained within
acceptable temperature limits. Special storage conditions ( ex.
Temperature , humidity ) shall be provided , monitored and
recorded , where required. Storage areas shall have appropriate
housekeeping and rodent ,pests and vermin control procedures and
records maintained.
 3.PRODUCTION AREA

The production area shall be designed to allow the production

preferably in unit-flow and with logical sequence of operations.
Working and in – process space shall be adequate to permit orderly
and logical positioning of equipment and materials and movement
of personnel to avoid cross – contamination.
In order to avoid risk of cross contamination , separate dedicated and
self – contained facilities shall be made available for the production
of sensitive pharmaceutical product like penicillin or biological
preparations with live microorganisms.
 4. ANCILLARY AREAS

Rest and refreshment rooms shall be separate from other areas and
shall not lead directly to the manufacturing and storage areas.
Facilities for changing , storing clothes and for washing. Separate
toilets for males and females not directly connected with
production or storage areas shall be provided. There shall be
written instructions for cleaning and disinfecting for such areas.
 5.QUALITY CONTROL AREA

Quality control laboratory shall be independent of the production

areas and divided into separate sections for physico- chemical
,biological , microbiological and radio – isotope analysis. There
shall be adequate area for basic installation and for ancillary
purposes. Arrangements like air – locks and laminar air flow
station shall be provided in microbiology section , if necessary .
The laboratory shall be designed to avoid mix –ups and cross-
contamination. Separate instrument room with adequate area shall
be provided for sensitive and sophisticated instruments employed
for analysis.
 6.PERSONNEL

The manufacture / testing shall be conducted under the direct

supervision of competent technical staff and head of quality
control laboratory shall be independent of the manufacturing
unit. Personnel for quality assurance and quality control
operations shall be suitably qualified and experienced. They shall
be provided with regular in-service training.
 7.HEALTH , CLOTHING AND
SANITATION OF WORKERS

All those engaged in the manufacturing processes shall observe a

level of personnel hygiene. Prior to employment all personnel
shall undergo medical examination and shall be free from
tuberculosis , skin and other communicable / contagious diseases.
All persons prior to and during employment shall be trained in
practices that ensure personnel hygiene. Smoking , eating ,
drinking , chewing or keeping plants , food , drink and personnel
medicines shall not be permitted in production , laboratory ,
storage and other areas.
8. MANUFACTURING OPERATIONS
AND CONTROLS

All manufacturing operations shall be carried out under the

supervision of APPROVED TECHNICAL STAFF. Trained
personnel under the direct supervision of approved technical
staff shall perform each critical step in the process relating to
the selection , weighing and measuring of raw materail
addition during various stages. The contents of all vessels
and containers used in manufacturing and storage shall be
conspicuously labelled with the name of the product , batch
size and stage of manufacture.
 9.SANITATION IN
MANUFACTURING PREMISES

The manufacturing premises shall be cleaned and maintained in an

orderly manner so that it is free from accumulated waste , dust ,
debris and other similar materail. A validated procedure shall be
maintained. A routine sanitation program shall be drawn and
observed and recorded.
 10. RAW MATERIALS
All raw materials shall be purchased from approved sources under
valid purchase vouchers , possibly from the producers directly.
There shall be adequate separate areas for materials under test ,
approved and rejected , under controlled temp.,humidity.
Authorized staff shall examine each consignment of raw materail.
All the conatainers of raw materials shall be placed on the raised
platform / racks and not directly on the floor.
 11. EQUIPMENT

Equipment shall be located , designed , constructed , adapted

and maintainted to suit the operations to be carried out. The
layuot and design of the equipment shall aim to minimise the
risk of errors and permit effective cleaning and maintenance in
order to avoid cross – contamination , build –up dust or dirt and
any adverse effect on the quality of the produts. Each equipment
shall be provided with a logbook , if necessary.
 12.DOCUMENTATION AND
RECORDS
Documentation is an essentail part of the QA system and , as such
shall be related to all aspects of GMP . Its aim is to define the
specification for all materials , methods of manufacture and control ,
to ensure that all personnel concerned with manufactured know the
information necessary to decide whether or not to release a batch of
a drug for sale and to provide an audit trail that shall permit
investigation of history of any suspected defective batch. Records
and associated SOPs shall be retained for at least one year after the
expiry date of the finished product.
13. LABELS AND OTHER PRINTED
MATERIALS

The labels shall carry all the prescribed details about the
product and shall be printed in bright colours and in alegible
manner. All containers and equipment shall bear appropriate
labels. Different colour coded labels shall be used to indicate
the status of a product ex. Under test , approved , passed ,
rejected . Unused coded and damaged labels and packaging
materials shall be destroyed and recorded.
 14.QUALITY ASSURANCE (QA)
This is a wide ranging concept concerning all matters that
individually or collectively influence the quality of a product. It is
the totality of the arrangements made with the object ensuring that
products are of the quality required for their indented use. Quality
assurance ensure that –
1. Adequate arrangements are made for manufacture , supply
and use of correct starting and packaging materials.
• The finished product is correctly processed and checked in
accordance with established procedure.
 15. SELF INSPECTION AND
QUALITY AUDIT
The concept of self-inspection shall be followed to evaluate the
manufacturers compliance with GMP in all aspects of production
and quality control. The manufacture shall constitute a team of
independent , experienced , qualified persons from within or
outside the company who can audit objectively the
implementation of methodology and procedure evolved. Written
instructions for self-inspection shall be drawn up which shall
include the personnel , premises including personnel facilities ,
maintenance of buildings and equipment, label control etc.
 16. QUALITY CONTROL SYSTEM
Every manufacturing establishment shall establish its own QC
laboratory manned by qualified and experienced staff.
QC is defined as ,"The regulatory process through which industry
measure actual quality performance .

Quality control shall be concerned with sampling , specifications

,testing , documentation and release procedure , which ensure that
the necessary and relevant tests are actually carried and that the
materials are not released for use , nor products released for sale or
supply until their quality has been judged to be satisfactory.
 17.SPECIFICATIONS

Specifications shall be available separately for raw materials and

packaging materials , product containers and closures , in-process
and bulk-products and finished products.
18. MASTER FORMULA RECORDS
There shall be Master Formula Records relating to all
manufacturing procedures for each product and product and batch
size to manufactured. These shall be prepared and endorsed by
the competent technical staff. The Master Formula shall include –
(a) the name of product ,
(b) the proprietry name of the product along with the generic
name ,
(c)name, quantity and reference number of all the starting
materials
(d) a statement of the expected final yield
(e)statement of the processing location and the principle
equipment
(f) Methods to be used
(g)Detail stepwise processing
(h)Instructions for in process control
(I)Requirement for storage conditions
(j) Any special precaution
(K) Packing details and specimen labels.
 19.PACKAGING RECORDS
Authorized packaging instructions for each product ,pack size
and type shall include the following –

Name, Dosage form,strength,composition and pack size,

Packaging materials, Special precaution, in-process control with
instruction
20.BATCH PACKAGING RECORDS

A batch packaging records shall be kept for each batch or part

batch processed. Before any packaging operation begins, checks
shall be made and recorded that the equipment and the work
stations are clear of the previous product and the equipment is
clean and suitable for use.
21.BATCH PROCESSING RECORDS

Batch processing record for each product shall be based on the

relevant part of the currently approved Master Formula. It
includes –
Name of product,
Batch no.,
Date and time of commencement,
Initial of the operators of different significant steps of
production, any relevant processing operations,
A records of the in-process controls,
Notes on special problem,
Addition of recovered or reprocessed materials.
 22.STANDARD OPERATING
PROCEDURES
( SOPs) AND RECORDS

There shall be written SOPs and records for

1. The receipt of each delivery of raw ,primary and printed
materials,
• Internal labeling
• Each equipment and instructions,
• Sampling,
• Batch no.,
• Testing,
• Records of analysis
8. Reference samples,
9. Reprocessing and recoveries,
10. Distribution records,
11. Product recalls,
12. Complain and adverse reaction,
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