The Agency is a recognised partner of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, jointly referred to as PIC/S.
PIC/S are two international instruments between countries and pharmaceutical inspection authorities. They aim to lead the international development, implementation and maintenance of harmonised good-manufacturing-practice (GMP) standards and quality systems of inspectorates in the field of medicines.
PIC/S achieves this by:
- developing and promoting harmonised GMP standards and guidance documents;
- training national regulatory authorities, particularly inspectors;
- assessing and re-assessing inspectorates;
- facilitating co-operation and networking for national regulatory authorities and international organisations.
The Agency works with PIC/S by:
- training GMP inspectors;
- developing harmonised guidance documents;
- sending a representative to PIC/S meetings.
PIC/S also has a representative participating in the Agency's GMP/Good Distribution Practice Inspectors Working Group.
The Agency also assists with assessment of the equivalence of authorities, inspection activities and the sharing of information on inspections.
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- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
- Good manufacturing practice and good distribution practice compliance
- Confidentiality commitment from the Pharmaceutical Inspection Co-operation Scheme not to disclose non-public information shared by the European Medicines Agency (11/07/2012)
- Addendum no. 1 to the cooperation between the Pharmaceutical Inspection Cooperation Scheme and the European Medicines Agency of 28 December 2010 (11/07/2012)
- Co-operation between the Pharmaceutical Inspection Co-operation Scheme and the European Medicines Agency (11/02/2011)