QAS-033 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 539

SOP No. QAS 033.00 Effective date: mm/dd/yyyy
Approved by:

required based on cGMP requirements as PICs, WHO, EU, and US FDA guidelines in coordination
with the concerned departmental managers.

52.4.9 S uPerSedeS
In the space for “Supersedes,” write “New” if the SOP is written for the first time or write the previ-
ous “Issued on” date of the previous SOP, if the SOP is revised.

52.4.10 i SSued on
In the space for “Issued on,” the QA manager will provide the date with 1 week margin from the
date of writing. Within this 1 week period, the SOP will be checked and approved.

52.4.11 r eview d ate
In the space for “Review Date,” write the SOP review date. SOPs review shall not exceed 30 days
from the date of review. The (validity) review date for systems SOP is 24 months (2 years). The
review date for fixed SOP is 60 months (5 years).

52.4.12 d iStriButed to
In the space for “Distributed to,” enter the names of the departments where the SOP is applicable
and will be used. To indicate the copy marked to, use preferably the position's abbreviation described
below or, if applicable, use department/section's abbreviation under these two headings separately.
The SOPs on display will also be marked in the “Distributed to” space.
The following table describes the positions and abbreviations to be used for SOP distribution and
the list of samples, signatures, and initials of the employees responsible for writing, reviewing,
approving, and authorizing the standard operating procedures.

Position Position abbreviation name signature initials

1. General manager GMR ____________ __________ ___________

2. Technical manager TM ____________ __________ ___________

3. Quality assurance manager QAM ____________ __________ ___________

4. Marketing manager MKM ____________ __________ ___________

5. Production manager PRM ____________ __________ ___________

6. Maintenance manager MM ____________ __________ ___________

7. Regulatory affairs manager RAM ____________ __________ ___________

8. Quality control manager QCM ____________ __________ ___________

9. Stores manager STM ____________ __________ ___________

10. Planning manager PMG ____________ __________ ___________

11. Packaging manager PKM ____________ __________ ___________

12. Quality assurance in-process QAI ____________ __________ ___________

13. Packaging officer PKO ____________ __________ ___________

14. Purchase manager PRM ____________ __________ ___________

15. Manager safety and security MSS ____________ __________ ___________