QAS-033 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 541

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

2. The “uncontrolled copy” will be destroyed in the shredder.

3. The QA manager will update the SOP index maintained on a computer with the following
details:

Master SOP Index

subject soP no. rev. no. supersedes date issued date effective date review date

4. The copies of the master SOP will be made as per the distribution list.

5. The SOPs distribution and retrieval record will be maintained in the SOP distribution
record register (Attachment 3) with full traceability.

6. The master superseded SOPs will be stamped “void” (red color) and kept for an indefinite
period in the QA archive.

7. The return superseded SOPs will be destroyed in the shredder.

52.4.20 a nnual SoP r eading /r ecord
All new SOPs, revised SOPs, and current SOPs will be read once in a year by the concerned staff
or explained to the concerned staff by the section in-charge regardless of the SOP training/evalua-
tion questionnaire. The reading or explanation will be documented on the reading record register
(Attachment 4) by the concerned manager. Not more than five SOPs should be read in a day.

52.4.21 a nnual SoP r eview

1. All systems SOPs shall be reviewed once every 12 months. And fixed SOPs will be
reviewed every 60 months as per the corresponding site procedure.

2. The QA manager will plan the SOP review as per the information provided in the master
SOP index.

3. The SOP will be forwarded to the person responsible for the review, except the QA systems
to be reviewed by QC or production to avoid conflict of interest.

4. If the SOP does not require revision, the review form will be closed out and returned to the
QA manager.

5. If the SOP requires revision, a separate change control form will be initiated as per
SOP , and closed-out after redistribution as per the existing standard operating

procedure.

52.4.22 S yStem SoP v alidity
All system-related SOPs are valid for a period of 2 years + 30 days for revision.

52.4.23 f fixed SoP v alidity

1. All procedures that are related to the fixed equipments and are highly unlikely to be
changed frequently will have 5 years SOP review date + 30 days for revision.