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GMP News
11 October 2005
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FDA Applies for PIC/S
Membership
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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.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
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Harmonised GMP requirements laid down by ICH are key topics of the
following events organised by the European Compliance Academy:
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ICH Q9/Q10:
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FDA's New Quality Systems and Risk
Approach
Barcelona, Spain, 10-11 November 2005
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ICH Q7A:
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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
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ICH Q6:
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Setting Specifications and Acceptance
Criteria
Barcelona, Spain, 28-29 November 2005
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ICH Q1:
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Stability Testing for Drug Substances and Drug Products
Barcelona, Spain, 29-30 November 2005
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ICH Q8:
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New GMP/ICH Requirements on Development
and Investigational Medicinal Products
Madrid, Spain, 1-2 December 2005
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