New Draft of Chapter 1 "Quality Management" of the EU GMP Guidelines Published

GMP News No. 883: New Draft of Chapter 1 "Quality Management" of the EU GMP Guidelines Published

GMP News
7 February 2007
 

New Draft of Chapter 1 "Quality Management"
of the EU GMP Guidelines Published

 
On 29 January 2007, the European Commission has published the revised Chapter 1 of the GMP Guide for public commenting.

The following statement has been published on the Webpage of the European Commission:

"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.

You can find the new document here.
  

The European Compliance Academy's ICH Q9 Training Course in Berlin, Germany, from 20-21 June 2007 deals with the practical implementation of the requirements in the ICH Q9 Guideline "Quality Risk Management".

Also, take advantage of the ICH Q 10 and FDA Quality System Training Course from 21-22 June 2007, providing information on the content and consequences of FDA's "Guidance for Industry: Quality System Approach to Pharmaceutical cGMP" and ICH's Q 10 "Quality Systems".

Further, practice-oriented approaches to assessing, controlling and reducing risks in "sterile processes" will be provided in the 2-day GMP Education Course Risk Management for Sterile Manufacturing from 17-18 April 2007 in Copenhagen, Denmark.

 
Prepared by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
  

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