QAS-022 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 366

SOP No. QAS-022.00 Effective date: mm/dd/yyyy
Approved by:
41.1 PurPose
The purpose of this SOP is to ensure that records and documents are retained for an appropriate and
specific period of time. The procedure applies to SOPs, technical documents, and documented
records of QA and QC departments.
41.2 resPonsibility
All concerned departmental managers are responsible for following the procedure. The QA director
is responsible for SOP compliance.
41.3 Procedure
1. All batch records must be retained for a minimum of shelf life of the batch + 2 years from
the corresponding date of manufacture of the batches. The records that are maintained in
batch files include
a. All manufacturing records
b. All packaging records
c. All in-process control records (line clearance, in-process checks)
d. All QC records (analytical reports, release certificates, labels, cartons, etc.)
e. All weighing area records
2. Any complaint related to the batch will be filed with the QA manager with the conclusion
and will be maintained in the “Complaint File” and will not be destroyed.
3. The master product specifications and the master test method (original) will be maintained
by the manager documentation. If there is any change in the product specifications and the
test method, then the old original copies will be filed in “ STM and product specification.” .”
These records/files will be maintained for a minimum period of 7 years from the date of
revision .
4. Validation reports (of equipment, process, systems, etc.) will be maintained in separate files and
these files will be updated whenever there is a revalidation maintaining the previous records.
The records will be maintained by the validation manager for an indefinite period.
5. Test method validation reports will be filed with the method validation group and will be
kept for an indefinite period.
6. Stability records of a product will also be maintained for an indefinite period in the R&D
laboratory.
7. The destruction of SOPs (master and copies) will be indicated by an asterisk in a column
of returned SOPs. All the changes in the SOPs are maintained under “Reasons for Revision”
in the current SOP.
8. All technical packages will be retained with systems for an indefinite period. The manager
documentation will keep the records for the superseded documents.
9. Product development records shall be retained with the R&D laboratory director for an
indefinite period.
10. All the packaging material approval records (development) will be maintained by the R&D
manager and will be retained for an indefinite period.
11. All the vendor approval samples records will be maintained by the QC laboratory in
“Archive” and will be maintained for an indefinite period.
12. Prescribing and patient information (a sample of each version) or patient guidance leaflet
will be retained for a minimum of 7 years from the date it ceases to be authorized for use.