Professional Organisations & Industry

Since the manufacturer is at the heart of the GMP process, it is essential for PIC/S to maintain good relations with industry and professional organisations, notably those more active in the field of regulation, guidance documents and training.  The support of industry associations and professional organisations to the goals of PIC/S is a prerequisite for the latter’s successful expansion.

As a matter of fact, industry is generally favourable to PIC/S’ expansion: the harmonisation of GMP facilitates trade and also means fewer inspections for manufacturers.  The latter are increasingly worried by the multiplication and duplication of inspections, which means not only more fees but also more staff immobilised and possibly a lower-than-usual production output during these inspections. 

PIC/S mainly entertains privileged relations with two professional associations: the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA). These two organisations provide valuable comments on draft PIC/S guidance documents and open their training courses to Regulatory Authorities, in particular to those of PIC/S, by providing a specific number of complimentary registrations. ISPE is sharing its technical guidelines with PIC/S inspectors, which are much appreciated, and actively provides speakers to PIC/S seminars. PDA works with PIC/S in the field of training, in particular on APIs (see International Training Programme on APIs).

PIC/S maintains relations with other industry and professional associations such as: