The Pharmaceutical Inspection Co-operation Scheme
Compliance and inspections
The European Medicines Agency (EMA) and many of the medicines regulatory authorities of the European Union (EU) Member States are involved in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of good manufacturing practice (GMP).
PIC/S aims to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of human and veterinary medicines. It achieves this by:
- developing and promoting harmonised GMP standards and guidance documents;
- training national regulatory authorities, particularly GMP inspectors;
- assessing and re-assessing inspectorates;
- facilitating cooperation and networking for national regulatory authorities and international organisations.
PIC/S develops and maintains a GMP guide to be used by its participating authorities, which is its main instrument for harmonisation. This is equivalent to the EU GMP guidelines in terms of GMP requirements.
Participation in PIC/S is open to any authority with a comparable GMP inspection system.
EMA role
EMA and PIC/S work together for better GMP harmonisation at international level and to share resources and avoid duplication of efforts. The cooperation focuses on:
- training GMP inspectors. This includes opening up training opportunities to other members, providing training materials and speakers and hosting training events;
- participating in each other's meetings. PIC/S has a representative on EMA's GMP/Good Distribution Practice (GDP) Inspectors Working Group and EMA attends PIC/s meetings;
- developing harmonised guidance documents. Through the GMP/GDP Inspectors Working Group, EMA ensures that the EU GMP guidelines remain fully harmonised with the PIC/S GMP guide.
The Agency also supports with assessment of prospective participating authorities' GMP equivalence, inspection activities and the sharing of information on inspections.
For more information, see:
- Co-operation between the Pharmaceutical Inspection Co-operation Scheme and the European Medicines Agency
- Working Arrangement between DG SANTE/EMA and PIC/S for the exchange of non-public information on medicinal products
- Addendum no. 1 to the cooperation between the Pharmaceutical Inspection Cooperation Scheme and the European Medicines Agency of 28 December 2010