PIC/S implements EU-GDP for APIs
![Ambient Transport and Cold Chain - Live Online Training](files/eca/userImages/training.img/Z-ECA-Ambient-Transport-and-Cold-Chain-Live-Online.jpg)
Recommendation
6/7 November 2024
Temperature controlled Transports of Medicinal Products
The PIC/S* adopts the Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1). It transposes the EU Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use for PIC/S purposes. According to a PIC/ news, this "adoption further strengthens harmonisation between PIC/S and the EU". The guidelines are more or less the same with some minor editorial differences.
Will PIC/S countries (like for example the US) now have to implement EU GDP?
According to the PIC/S GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICE OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE, "it is up to each PIC/S Participating Authority to decide whether it should become a legally-binding standard."
*The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 52 participating authorities coming from Europe, Africa, America, Asia and Australasia.
Related GMP News
16.07.2024Templates for Shortage Prevention and Mitigation Plans issued by EMA
16.07.2024New Measures to Report Medicine Disappearances
16.07.2024GDP Non-Compliance Report for Czech Wholesale Distributor
16.07.2024Checklist for Implementation of GDP Principles - Part 9: Transportation
12.06.2024EU adopts Supply Chain Law - Implications for pharmaceutical Companies