EU GMP Guide - further proposals for amendment

The pace of amendments to the EU GMP Guide certainly shows no sign of slackening: there have recently been three further drafts issued by the European Commission proposing amendments to various chapters and annexes of the Guide.

These relate to proposed amendments to Part II of the Guide on active pharmaceutical ingredients and to Annex 13 of Part I on investigational medicinal products. There is also a proposed revision of Annex 11 on computerised systems that also involves related changes to Chapter 4 of Part I of the Guide on Documentation

In relation to Part II, the Guide Principles of Quality Risk Management have been included, which are similar to those made to Part I Chapter 1 of the Guide and published in February 2008. In its commentary on the draft proposals the Commission states that further changes to Part II of the Guide beyond the implementation of ICH Q9 are currently not foreseen and would require proper discussion at ICH.

As regards Annex 13, the Commission has deemed it necessary to clarify certain points related to reference and retention samples, the two-step release procedure for investigational medicinal products and to the principle of independence between production and quality control functions.

The proposal to update Annex 11 on computerised systems has been made in response to the growth in use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide (Documentation).

Comments from interested parties are invited by 31 October and details can be found at http://www.emea.europa.eu/Inspections/WhatsNew.html

The proposed changes highlight the rapidly increasing pace of developments in GMP and also the increasing importance and acceptance of the application of the principles of Risk Management in the GMP arena.