PIC/S implements EU-GDP for APIs

Recommendation

11/12 March 2020
Berlin, Germany

The Responsible Person for Good Distribution Practice (GDP)

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.