The Pharmaceutical Inspection Co-operation Scheme

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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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