FDA Applies for PIC/S Membership

GMP News No. 623

GMP News
11 October 2005

FDA Applies for PIC/S Membership

The US-American FDA has taken a further step announced within the framework of the initiative cGMP for the 21st Century. Apart from the harmonisation efforts via the International Conference on Harmonisation (ICH), the FDA handed in its application for PIC/S membership on 16 September 2005.

The English medicines authority MHRA was appointed by PIC/S as co-ordinator of a team of 6 experts. PIC/S membership is only granted after an extensive evaluation procedure. In the months to come, PIC/S will have a close look at FDA's GMP inspectorates.

At the moment, a total of 28 countries is organised in PIC/S. The current list of countries can be viewed  here. It is PIC/S' objective to drive GMP harmonisation forward. Two means to reach this aim are harmonised guidelines and recommendations.

Oliver Schmidt


Harmonised GMP requirements laid down by ICH are key topics of the following events organised by the European Compliance Academy:
ICH Q9/Q10: 

FDA's New Quality Systems and Risk Approach
Barcelona, Spain, 10-11 November 2005


Chapter 19 ICH Q7A: APIs for Use in Clinical Trials
Prague, Czech Republic, 8-9 November 2005
ICH Q7A Compliance for APIs Manufactured by Chemical Synthesis
Barcelona, Spain, 30 January - 1 February 2006
ICH Q7A Compliance for APIs Manufactured by Cell Culture/Fermentation
Barcelona, Spain, 30 January - 1 February 2006
Certified ICH Q7A Auditor Training Course
Barcelona, Spain, 1-3 February 2006


Setting Specifications and Acceptance Criteria
Barcelona, Spain, 28-29 November 2005


Stability Testing for Drug Substances and Drug Products
Barcelona, Spain, 29-30 November 2005


New GMP/ICH Requirements on Development and Investigational Medicinal Products
Madrid, Spain, 1-2 December 2005


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