Complaints and product recall (Chapter 8, Part I - finished dosage form)

Counterfeit products

Clauses 8.7 and 8.8 of the PIC/S Guide to GMP require that the procedures on complaints handling should include an assessment for counterfeit products. If counterfeiting is detected the TGA must be notified in accordance with the Uniform Recall Procedure for Therapeutic Goods (URPTG).