The revised guide adopts Chapter 6 in parallel with the EU GMP Guide to include a new section on "On-Going Stability Programme".

As PIC/S points out in its introduction of the new guide, the harmonisation of the PIC, PIC/S and the EU GMP rules was agreed on to help "facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products throughout Europe."

As further laid out in the introduction, the editorial changes necessary to adapt the EU Guide to the Convention's purposes and requirements were:

• "the definition of Pharmaceutical Product (referred to as "Medicinal Product" in this Guide) which is found in Article 1 of the Pharmaceutical Inspection Convention has been retained;

• references to the EU Directives have been deleted;

• as the expression "Qualified Person" does not exist under the PIC or PIC/S , it has been replaced by "authorised person" (see Glossary)"

• since all the Contracting States to the PIC Convention or Participating Authorities under the PIC Scheme are not parties to the European Pharmacopoeia Convention, the mention of "European Pharmacopoeia" in the Guide has been amended to read "European or other relevant Pharmacopoeia"."

The revised PIC/S guide to GMP for Medicinal Products became effective 1 June 2006. It is available here.

Prepared by:
Wolfgang Heimes
On behalf of the European Compliance Academy