1. Do the packaging operations proceed following the instructions and using the specified materials described in the Master Packaging Procedure?
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 from 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?
e. 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 on each line prior to packaging to ensure
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 the 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?
20. Are printed packaging materials found during clean-up
a. turned over to the supervisor in the packaging area?
b. placed in specially designated containers (for reconciliation and destruction at the end of packaging run)?
21. Are finished or semi-finished packages observed off the packaging
a. given to the supervisor of the packaging?
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?
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?
c. status?
23. Are measures taken to control the spread of dust during packaging especially of dry products by;
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?
25. Is use of brushes discouraged?
26. Is bringing personal medicament into the packaging area prohibited?
27. Is placing of packaging components or products in the pocket of the personnel prohibited?
28. Are supplies like lubricants, adhesive, inks, cleaning fluids etc. kept in
a. a container different from the use of drug containers?
b. clearly labeled as to their contents?
Completion of the packaging operation
29. Is the last production package carefully checked to confirm with specification on completion of the packaging operation?
30. Is only finished products form a single packaging operation placed in a pallet?
31. Is the quantity of the partly filled carton indicated accordingly?
32. Is inspection performed on each line after the packaging operations, to ensure that
a. all excess packaging components
b. remaining bulk product, or
c. rejected packaging components
33. are removed, and after reconciliation closely supervised to ensure that only save and properly 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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