QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 137

SOP No. QAS-002.00 Effective date: mm/dd/yyyy
Approved by:
5. The file samples and batch documents will be physically checked and reviewed and if
required, chemical or microbiological testing will be performed on reference/complaint sam-
ples after approval from the director QA and findings will be recorded on the “Investigation
Form” (Attachment QAS-040-IV). Batch document review will also be carried out.
6. Depending on the possible nature of the complaint, finished products, raw materials, or the
packaging materials may be reanalyzed by the QC and reported.
7. After all the investigation work is completed, a conclusion will be drawn to ensure the
validity of the complaint and to initiate corrective actions appropriate to the nature of the
complaint.
8. Quality assurance director is responsible for replying to the complainant.
9. Quality assurance director may suggest calling on legal assistance before framing the
response only after consultation with the company's head.
10. If the complaint is of product quality, it may sometimes be compensated by supplying a
replacement of the same size and product, together with an appropriate letter of explanation.
11. If the complaint concerned efficacy and side effects, legal advice may be sought before
making any form of settlement.
12. All complaints received (Customer Quality Complaint Sheet), review and investigation
form along with the corrective action will be maintained in a separate file marked Market
Complaints.
21.4 documentation
Attachment I : Customer complaint sheet
Attachment II : Product complaint receipt form
Attachment III : Complaint classification form
Attachment IV : Finished product complaint (investigation form)
Attachment V : Batch document review
Attachment VI : Investigation time extension
21.5 reason for revision
First time issued for the ABC Pharmaceutical Company.