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This draft guidance is being issued consistent with FDA's good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 The draft guidance,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
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