What's New?

The following changes have been made to the GMP Guide:

• Chapter 1 has been revised as an implementation measure related to the ICH Q9 guideline on quality risk management. Whilst quality risk management has always been a founding principle of GMP the amendments make it clearer that quality risk management should be an integral part of a manufacturer's quality system.
• A revised Introduction to the GMP guide provides background on the implementation of these revisions.
• Annex 1 has been revised which takes effect 1 March 2009 except for the provisions on capping of freeze dried vials, which come into operation by 1 March 2010. Both revised and current versions of this annex are included.
• A new Annex 20 (Quality Risk Management) is included, implementing the ICH Q9 guidelines.

This online version coincides with the publication of the 2007 print edition.

Since the previous (2002) print edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (the “Orange Guide”) there have been many changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP). In addition, there is a new Directive dealing specifically with GMP and the Community code relating to medicinal products for human use (Council Directive 2001/83/EC) has itself been the subject of substantial revision, via amending Directive 2004/27/EC, and these changes have been transposed into UK domestic legislation.

The UK’s Code of Practice for Qualified Persons has been updated by the professional bodies in consultation with the MHRA; this is included.

Recommendations on meeting the important requirement to ensure the “proper conservation and distribution” of medicines requiring storage below ambient temperature (“cold-chain distribution”) have been developed between representatives of wholesalers and the MHRA. These were published originally in the Pharmaceutical Journal, were summarised in MAIL, and are reproduced here in updated form.

Finally, there is a new section on the activities and services of the Inspection and Standards Division of the MHRA, which will be of interest to manufacturers and wholesalers.

Although much of the text in this publication is available in its original form in other places, including various websites, the “Orange Guide” continues to satisfy a demand for information in one authoritative, searchable and convenient place.