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PIC/S: GMP Guide revised

The PIC/S has published its revised GMP Guide (PE 009-10) in December. The amendments relate to Chapter 4 (Part I, Documentation) and Annexes 6 (Medicinal Gases), 7 (Herbal Medicinal Products), 11 (Computerized Systems) and 13 (Investigational Medicinal Products).


The revised GMP-Guide is intended to bring forward the high quality standards in the areas of development, manufacturing and control of medicinal products. The content of the PIC/S GMP Guide is almost identical with the EU GMP Guide, both documents have been developed in parallel, whenever a change has been made to one of them, the other has been amended as well.

The differences are marginal and as follows:

  • the definition of Pharmaceutical Product (referred to as “Medicinal Product” in the PIC/S Guide), which is found in Article 1 of the Pharmaceutical Inspection Convention, has been retained;
  • references to the EU Directives, as well as to MRAs, have been deleted in the PIC/S Guide;
  • the expression “authorized person” is used in the PIC/S Guide while the expression “Qualified Person” is used in the EU Guide;
  • since not all Participating Authorities under the PIC Scheme are parties to the European Pharmacopoeia Convention, the mention of “European Pharmacopoeia” in the EU Guide has been amended to read “European or other relevant Pharmacopoeia” in the PIC/S Guide.

The revised PIC/S GMP Guide entered into force on 1 January 2013.

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