QAS-023 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 373

SOP No. QAS-023.00 Effective date: mm/dd/yyyy
Approved by:
10. Proper formats for date and time are used.
11. All abbreviations are approved and standardized.
12. Blank spaces are properly handled.
13. The original entry is made into the official record.
Good documentation skills should produce proper records with the following characteristics:
a. Permanent
b. Accurate
c. Prompt
d. Clear
e. Consistent
f. Complete
g. Direct
h. Truthful
42.5 sterile Production area
1. In clean room operations, employees should be correctly attired according to the relevant
SOP.
2. A fresh set of garments is used on each entry into the clean room.
3. A set of garments ready for use should be sealed and labeled.
4. The sterile production area should be in a good state of repairs and neat.
5. A person ill or suffering from cold or cough or having an open or bandaged wound should
inform to the supervisor and should not be allowed in the clean room areas.
6. The relevant cleaning procedure and schedule for the area and equipment should be
followed.
7. Cleaning and sanitization agents should be as per the SOP and labeled with the expiry
date.
8. Records to be maintained for the preparation of cleaning and sanitization agents.
9. No simultaneous opening of doors occurs on the clean and less clean class.
10. All the alarm systems are functional.
11. Work areas are clearly labeled.
12. Product and product components are exposed only where protected by laminar air flow
(LAF) stream providing an air quality of 100 or better.
13. Handling and all the working practices should be such as to avoid contamination and gen-
eration of particles.
14. All vessels and utensils are labeled as to their cleanliness status.
15. Manufacturing instructions are at hand during processes and are approved and accurately
followed.
16. Vessels should be labeled with the product lot number and the stage of processing.
17. Relevant sterilization and other charts and printouts are fully labeled, verified, and
approved.
18. Valid calibration labels on all equipment.
19. Air inlets and outlets are functional.
20. Material-holding containers are intact and can be closed completely.
21. Materials and personnel flow is dedicated and being followed.