PQS Flashcards
What details should you collect in the event of a product complaint?
Chapter 8- product complaints and recall
Date/time of complaint + defect found
Name/address of complainant
Product information
-Batch number EXP
-Serialisation details
- Strength, dosage form
- Storage conditions kept
Nature of complaint
Address of pharmacy/wholesaler
Date purchased
What would you expect to be in a typical complaint investigation?
Initial date collection on batch/ complainant.
Assessment of patient/ user risk
Consideration for PV reporting for ADRs
Initial maufacturing/QC/Storage review
Assessment of returned/ in house samples
QC analysis of samples/raw materials
Review of other batches
Investigation considering counterfeit
Conclusion- RCA and CAPAs
Report (PV in mind)
Response to complainant
Track and trend of complaints
