PIC/S Publishes New Version of GMP Guide

GMP News
19 September 2007
 

PIC/S Publishes New Version of GMP Guide

 
On 30 August, the Pharmaceutical Inspection Cooperation Scheme (PIC/S) adapted the PIC/S GMP Guide to the structure of the EC GMP Guide. Through this measure, there are only few differences between the two documents left.

Like the EC GMP Guide, the PIC/S Guide is now divided into a Part I concerning GMP for medicinal products and a Part II regarding GMP for active pharmaceutical ingredients. Thus, PIC/S also placed the former Annex 18 Guide "GMP for APIs" as an equivalent document next to Part I for medicinal products. Therefore, in addition to the requirements laid down in Part II (identical to ICH Q7), all annexes are now relevant for the manufacture of active pharmaceutical ingredients as well. Here, PIC/S will have to modify the annexes, like the EU will do. This is important e. g. with regard to Annex 1 "Sterile Manufacture" because the Annexes have been written with a focus on medicinal products, but not on APIs. Against the background of the re-structuring, a revision of the Annexes is inevitable.

With the revision, the new requirements on the Product Quality Review (PQR) and on-going stability have been integrated into the PIC/S Guide, too.

However, there are also some differences between the PIC/S Guide and the new EC GMP Guide:

  • The PIC/S does not know the function of the Qualified Person as defined by EU legislation. Therefore, the Guide calls this function "Authorised Person". For this reason, Annex 16 on "Certification by a Qualified Person and Batch Release" does not exist in the PIC/S Guide.

  • All references to EC Directives in the GMP Guide were deleted.

  • Since not all PIC/S members are in the European Pharmacopoeia, the PIC/S Guide does not only refer to the EP, but also to other relevant pharmacopoeias (e. g. JP or USP).

The choice of title is a bit unfortunate for Part II of the PIC/S GMP Guide. In contrast to the EC GMP Guide, it does not have the subtitle "Basic Requirements for Active Substances used as Starting Materials".

In the following you will find the links to the new guide:

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (PART I)
http://www.picscheme.org/publis/guides/PE 009-7 GMP Guide (Part I Basic Requirements for Medicinal Products).pdf

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART II
http://www.picscheme.org/publis/guides/PE 009-7 GMP Guide (Part II Basic Requirements for APIs).pdf

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (ANNEXES)
http://www.picscheme.org/publis/guides/PE 009-7 GMP Guide (xAnnexes).pdf
 

GMP Training Course recommendation:

Get a comprehensive overview of the documentation requirements according to the different international GMP Guides. Experts from API and pharmaceutical industry will show you possibilities to improve your systems and how to run them efficiently and (c)GMP-compliant.

GMP and FDA compliant Quality and Documentation Systems, 22-23 October 2007, Copenhagen, Denmark

 
Compiled by:
Oliver Schmidt
On behalf of the European Compliance Academy
 

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