FDA Published ICH Q9 "Quality Risk Management"

GMP News No. 591

GMP News
22 August 2005

FDA Published ICH Q9 "Quality Risk Management"

After EMEA's publication of ICH Q9 "Quality Risk Management" (Step 2) for the European Union, FDA now also published this document on 5 August 2005.

The FDA wrote on this occasion:

[...] This document supports FDA's "Pharmaceutical Current Good Manufacturing Practices for the 21st Century" Initiative, which was intended to bring a 21st century focus to the regulation of pharmaceutical manufacturing and product quality. One objective of this initiative is to encourage the implementation of risk-based approaches that focus both industry and agency attention on critical areas.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on Q9 quality risk management. [...]

You can download the document here.

Compiled by: Oliver Schmidt

Would you like to know more about the new risk-based approach and the new quality system approach of FDA? Our top event with former FDA Deputy Director International Affairs Staff Jim Lyda provides you with detailed information on this topic:

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


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