QAS-023 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 371

SOP No. QAS-023.00 Effective date: mm/dd/yyyy
Approved by:

18. Devices for the presence of labels and overprinting were challenged prior to the initiation
of work.
19. Effective segregation of printed materials from not printed and rejected ones.
20. Utilities lines are clearly marked and labeled.
21. Storage of product (bulk and finished) is under their labeled or prescribed storage
conditions.
22. All records must be completed at the time of action.
23. Employees have undergone training in the following areas:
a. GMPs
b. SOPs
c. Sterile area techniques and respective SOPs are followed.
24. Employees have full knowledge of their job functions.
25. Each department is well maintained for cleanliness and is spacious enough for equipment
and operations.
26. The area and equipment are clean at the end of the day's work.
27. Specific procedures for the cleaning of major equipments are followed.
28. Daily calibration records of balances are up to date.
29. Correction to writing errors are made by crossing out, with initial, date, and reason
(if necessary).
30. All the products have status label.

31. All the log books (equipment/area usage records) are updated.

42.3.2.2 stores and Weighing area
1. Weighing and measuring equipments used are of appropriate accuracy and are calibrated.
2. All incoming supplies of raw material and packaging commodities are stored as per SOP.
3. Stores receiving labels are fixed on all containers and sampled labels are affixed as
appropriate.
4. Release labels are fixed on approved items and rejected labels on rejected items.
5. All rejected items are kept segregated from other materials.
6. Cleaning in the area is done according to schedule and is very effective.
7. Workers (coming into direct contact with the product) are wearing clean masks.
8. The door of the weighing booth during dispensing is closed to avoid cross contamination.
9. Dispensed materials are kept in locked, clean cages with proper label.
10. Log books of the weighing area and calibration records of weighing balances are updated.
11. Raw material card entries are on time, complete and correct.
12. Temperature and RH are within the requirements and limits and the records are
maintained.

13. Storage of the raw materials, packaging materials, bulk products, and finished products is
done appropriately.

42.3.2.3 solid dosage Production area

1. Return ducts or exhaust in the production and filling areas are working properly.

2. RH and temperature are within limits, as per requirements of the product.

3. Workers (coming into direct contact with the product) are wearing clean masks.

4. Operators wear disposable gloves while touching the product.

5. All the products have status labels.

6. All the other respective SOPs are being followed.