Compliance with Good Distribution Practice (GDP) by manufacturers and wholesale distributors is a key element in ensuring the quality and safety of medicinal products in the supply chain.
Possession of a manufacturing licence may include authorisation to distribute the medicinal products covered by the authorisation. Manufacturers performing any distribution activities consisting of procuring, holding, supplying, importing, or exporting medicinal products, should therefore comply with GDP.
PIC/S has developed an Aide Memoire “Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain” (PI 044-1)”, which can be considered a good tool for improving the understanding and performance of inspectors and a “Questions & Answers (Q&A) document regarding the PIC/S GDP Guide” (PS/INF 22/2017).
These documents were drafted by the PIC/S Expert Circle on GDP and came into force on February 1, 2023.
The Aide-Memoire consists of ten tables containing general subjects and items to be investigated during the GDP inspection of manufacturers and wholesale distributors.
Some relevant references to the following PIC/S documentation are also included:
- PICS Guide to Good Distribution Practice for medicinal products (PE 011- 1);
- PIC/S Guide to GMP for medicinal products (PE 009-16 (Part I)).