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Pharmaceutical Guidelines:ISO, FDA, USFDA, ICH, WHO, GMP, MHRA guideline, Validation Protocol, SO

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validation, ICH guidelines, GMP audut compliance, equipment qualification, Installation Qualification, Operational Qualification, Performance
Qualification, Calibration, Validation Protocol, SOPs etc.

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GMP Audit Check List- Filling and Packaging

1. Do the packaging operations proceed following the instructions and using the specified materials
described in the Master Packaging Procedure?

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2. Are the details of the operation recorded on the Batch Packaging Record?
3. Is only one product batch and packaging size on a line at any given time?
4. Are all deliveries of bulk product and packaging components checked and verified for their correctness
against the Master Packaging Procedure of other specific order?
5. Is the first precoded packaging compound checked on the correctness of the printed codes?
6. Are components allocated for pre-coding stored in sealed containers within an appropriate area for
proper security and segregation?
7. Does pre-coding of components take place in an area isolated form other packaging operations?
8. Are all pre-coded components checked against the correctness before transfer to packaging?
9. Are there procedures describing
a. receipt and identification of bulk ,packaging components?
b. proper control to assure the correct, printed and unprinted packaging component used?
c. the required in-process control?
d. the reconciliation of bulk products and printed packaging materials?
final package examination?
Line clearance
10.
Before a packaging operation starts, are checks carried out to ensure that work area and
equipment are clean and free form
a. any products?
b. product residues? Or
c. documents not required for that operation?
11. Is an inspection conducted of each line prior to packaging to ensure

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a. removal of all previous drug product and labeling materials?

b. general cleanliness of the line and the immediate area?
c. cleanliness of the equipment to be used? Employed
12. Is there inspection verified by Quality Control?
In-process control
13. Are there procedures for in-process control describing,
a. the point of sampling?
b. the frequency of sampling?
c. number of samples to be taken?
d. specification to be checked?
e. the limit of acceptability for each specification?
14. Does the in-process control include;
a. checking of the product till or count at the start of the packaging run?
b. checking of the finished products through-out the run at regular intervals for their full compliance with
specifications?
c. checking of batch identity through-out the packaging operation?
15. Are the results of in-process tests and inspection
a. recorded?
b. included in the Batch Packaging Record?
Operating practices
16. Is there adequate separation of packaging lines to prevent any mix-up?
17. Is each packaging line identified with product name, pack, size and batch number?
18. Are storage containers for a bulk product, partly packed product or sub-batch labeled and marked
with;
a. product identity? b quantity? C batch number? d status?
19. Are the empty containers to be filled supplied to packaging line or station in a clean condition?
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20. Are printed packaging materials found during clean-up

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a. turned over to the supervisor in the packaging area?

b. placed in special designated containers (for reconciliation and destruction at the end of packaging
run)?
Pharma
21. Are finished or semi-finished packages observed off the packaging
a. given to the supervisor of the packaging?

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b. never returned directly to the packaging line?

c. scrapped and the amount recorded, if the package cannot be identified for the same batch or lot
number?
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22. Are products filled into their final containers and awaiting labeling and final packaging segregated and
marked with the;
a. product identification?
b. batch number?

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23. Are measures taken to control the spread of dust during packaging especially of enter
dry products

a. using dust collecting device?

b. discouraging use of compressed air?
24. Is a segregated area provided for filling and packaging of potent low dose or toxic products or
sensitizing agents?

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ISO Guidelines
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ICH Guidelines

25. Is use of brushes discouraged?

MHRA-UK Guidelines

26. Is bringing personal medicament into the packaging area prohibited?

MCC Guidelines -South Africa

27. Is placing of packaging components or products in the pocket of the personnel prohibited?

TGA Guidelines-Australia

28. Are supplies like lubricants, adhesive, inks, cleaning fluids etc. kept in

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a. a container different form the use for drug containers?

Schedule M-India

b. clearly labeled as to their contents?

European Guidelines

Completion of the packaging operation

MEDSAFE Guidelines -Newzeland

29. Is the last production package carefully checked to confirm with specification on completion of the
packaging operation?

GCC Guidelines -Gulf

30. Is only finished products form a single packaging operation placed in a pallet?

PANDRH Guidelines -American

31. Is the quantity of the partly filled carton indicated accordingly?

PIC/S Guidelines

32. Is inspection performed on each line after the packaging operations, to ensure that

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a. all excess packaging components

Drugs & Cosmetics Act-India

b. remaining bulk product, or

APIC Guidelines

c. rejected packaging components

EU Guidelines

PDMA Guidelines -Japan

33. are removed, and after reconciliation closely supervised to ensure that only save and properly

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identified packaging components and bulk products are permitted to be returned to the warehouse?
34. Are all excess or rejected coded packaging materials
a. counted?

b destroyed under control of the supervisor?

35. Are quantities destroyed recorded on the Batch Packaging Record?

36. Is the net used packaging components and bulk products calculated and recorded by the supervisor?
37. Is any significant unexplainable yield discrepancy or failure to comply with specification thoroughly
investigated?
38. Is the investigation extended to other batches or other products which might also be affected?
39. Are finished products quarantined until final release by Quality Control?
40. Is the removal of excess packaging component and bulk products after reconciliation closely
supervised?
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Non-sterile Process Validation in
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Clean Room System in Sterile
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GMP Audit Check List- Weighing and
Dispensing
GMP Audit Check List- Filling and Packaging

What is 21 CFR ?
This is the code for Fedral Regulations, sush
as 1,2,3,...21,....40 etc. Those Numbers has
different Headings such as 21 CFR- Food and
Drug. These Headings has chapters I,II,III etc.
There are parts in every CFR, like Part 211 is
of Current Good Manufacturing Practices or
Finished Pharmaceuticals of the CFR 21. Again
part is divided into the subparts as A,B,C,D....Z.
Subparts are divided into various sections,It is
a part no. with sr.no. such as section 211.1
USFDA guideline or Finished Pharmaceutical
Products is given under 21 CFR part 210 and
211.

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