1. Is the area equipped to avoid cross-contamination and physically separated from the other rooms by walls or other type of separation?
2. Are lighting and ventilation adequate?
3. Is there temperature and humidity control, where required?
4. Are weighing and dispensing area maintained in a clean condition?
5. Are sterile raw materials weighed and dispensed in the sterile area?
6. Is the area adequately staffed?
7. Is there proper supervision in the area?
8. Have the personnel received GMP training?
9. Do the personnel receive up-dated training?
10. Are personnel wearing appropriate clothing?
11. Is protective clothing (gloves, caps, masks etc.) used during the weighing operations?
12. Are the utensils used for weighing (receptacles, scales, hoppers, spatulas, pipettes etc.) properly cleaned after each use?
13. Are these utensils kept in an appropriate place which is free from contamination?
14. Are the scales and balances used for weighing calibrated regularly?
15. Are these recorded?
16. Are records for these calibrations maintained?
17. Are the containers of the raw materials to be weighed cleaned before being opened?
18. After weighing, are these containers well sealed?
19. Are raw materials or components for each batch properly identified and segregated after weighing?
20. Does this identification include:
a. The name of the raw materials or component?
b. The batch and another control number of the raw material or component?
c. The batch number of the drug product to be manufactured?
d. The quantity that was weighed?
e. The signature/initial of the weigher and the checker?
21. Is a control system governing the issuance of starting materials, intermediate products and bulk products available?
22. Are there written procedures for handling, weighing, counting and dispensing
a. raw materials? b. packaging materials?
23. Are only the relevant raw materials, intermediate products and bulk products located within the dispensing area?
24. After weighing, dispensing and labeling, are raw materials, intermediate products and bulk products transported and stored in a manner that will preserve its integrity until further processing?
25. Is only one particular printed packaging material permitted in a single coding station at a time?
26. Is adequate segregation provided between coding stations?
27. Prior to weighing and dispensing, is each container of raw materials checked for proper labeling, including the approval label from quality control?
28. Are capacity, accuracy and precision of weighing and measuring equipment used appropriately to the number of materials to be weighed or measured?
29. For any weighing or measuring operation do at least two persons independently verify the correctness of the identity and amount of weighed or measured material?
30. Are dispensed raw materials intermediate and bulk products rechecked for accuracy and signed by the production supervisor prior to delivery to the production area?
31. Are all raw materials, packaging materials, intermediate and bulk products returned to storage areas properly documented and reconciliation?
32. Is return of raw materials, packaging materials, intermediate and bulk products prohibited unless they meet their defined specification?
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