QAS-023 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 374

SOP No. QAS-023.00 Effective date: mm/dd/yyyy
Approved by:
22. Air differentials are maintained between the different areas of processing as per their lev-
els of cleanliness.
23. Temperature and humidity are within the limits.
24. Dispensing and all the processing are being carried out in the prescribed and dedicated
areas.
25. Line clearance procedure should be strictly followed and counter checked to avoid
mix-up.
26. Devices for the presence of labels and overprinting challenged prior to initiation of work.
27. Effective segregation of printed materials from nonprinted and rejected materials.
28. Utility lines are clearly marked and labeled.
29. Storage of product (bulk and finished) is under their labeled or prescribed storage
conditions.
30. All records must be completed at the time of action.
31. Watches, bracelets, jewelry, or rings should not be worn during work.
42.5.1 “d o ” S to B e f followed
1. Do wear identification card all the time at work.
2. Do follow clothing instructions before entering the plant.
3. Do wash hands before entering and leaving the personal facility.
4. Do read, understand and follow standard operating procedures related to your work.
5. Do follow GMP at work.
6. Do observe personal hygiene at work.
7. Do keep your nails clean and cut them every week.
8. Do get a haircut every month.
9. Do keep your beard trimmed every day before coming to work.
42.5.2 “d o n ot ” S to B e f followed
1. Do not take food and drinks inside the plant; in particular, do not eat chewing gum.
2. Do not enter into the plant in personal clothing, street shoes, and unwashed hands.
3. Do not go to the bathroom and outside the plant in your working uniform, head cover, and
clogs.
4. Do not enter the plant if suffering with some contagious disease or a lesion over the skin.
5. Do not carry an antidust face mask, disposable hand gloves, and other working tools to
your lockers.
6. Do not keep medicines inside the locker, except those prescribed for personal use by the
doctor.
7. Do not carry batch record and support documents in your pockets and lockers.
8. Do not remove medicines from the line for personal use.
9. Do not taste or touch raw materials for personal experience during dispensing and
processing.
10. Do not change labels from the container unless authorized.
11. Do not remove items from the pallets unless authorized.
12. Do not cough inside the plant without handkerchief.
13. Do not use cosmetics and jewelry at work.
14. Do not keep used sanitary towels inside the lockers.