Thursday, 16.04.2012

EU GMP Guide Chapter 1 "Quality Management" under Revision

The European Commission has published the revised Chapter 1 of the GMP Guide for review and commenting.

The European Commission posted this revision with the following introduction on their web page:

"Chapter 1 of the GMP Guide has been amended to include reference to the quality risk management principles as described in the ICH Q9 guideline. The amendment is part of the EC implementation measures for the ICH Q9 guideline on quality risk management. The changes made are restricted to the principle and a new section 1.5. Unrelated changes have been made to the numbering and in section 1.1(i).

While the risk management principles will be included in Chapter 1, the most appropriate way to fully integrate the ICH Q9 guideline to provide risk management methodology and tools to be used at the discretion of the manufacturer is currently under discussion. An integration into the GMP guide is currently being considered."

Public comments to the revised Chapter 1 should be sent to entr-gmp@ec.europa.eu and gmp@emea.europa.eu by 30 April 2007.

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new.htm

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