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 three professional associations: the International Society for Pharmaceutical Engineering (ISPE);  the Parenteral Drug Association (PDA) and the European Compliance Academy (ECA) These 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. ECA, ISPE and PDA are sharing their technical guidelines with PIC/S Inspectors, which are much appreciated; and ISPE and PDA actively provide speakers to PIC/S Seminars. PDA has also worked with PIC/S in the field of training, in particular on APIs (see International Training Programme on APIs) and all three organisations have expressed interested in supporting the PIC/S Inspectorates’ Academy (PIA).

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

  • APIC (Active Pharmaceutical Ingredients Committee)
  • ASTM International (American Society for Testing and Materials)
  • DIA (Drugs Information Association)
  • EFPIA (European Federation of Pharmaceutical Industries and Associations)
  • Global Self-Care Federation
  • IFPMA (International Federation of Pharmaceutical Manufacturers Associations)
  • ISCT (International Society for Cell & Gen Therapy)
  • RAPS (Regulatory Affairs Professionals Society)
  • SQA (Society of Quality Assurance)
  • VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products)