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On 29 September, the FDA issued the final Guidance on Quality Systems to
facilitate the modernisation of drug manufacturing. It is somehow
surprising how quickly this guidance was finalised. And it underlines how
important this topic is to the FDA. Harmonisation efforts with ICH Q10
cannot be seen in this document.
When comparing the final guidance with the draft document, one can see
that mostly changes in the wording have been made. Nevertheless, in some
cases the different wording results in a different meaning. For example,
the draft document "is not intended to create new expectations ..."
whereas the final guidance "is not intended to create new requirements
...". So the FDA does give a clear statement on what their expectations
are regarding the Quality System. In the case of validation, the FDA
mentions the ASQ document (The ASQ Auditing Handbook, 3rd edition, ASQ
Quality Audit Division, J.P. Russel, Editor) and not the "old" FDA Process
Validation Guide.
On the whole, there are no big changes compared to the draft. But now,
the FDA has issued a guidance which implements ISO 9001 elements, Quality
Risk Management and a CAPA system in their expectations. "This guidance
incorporates modern quality principles into FDA's approach to
manufacturing, encouraging industry adoption of new technological advances
and integrated quality systems." said Dr Janet Woodcock, FDA Deputy
Commissioner for Operations.
This document contributes to the goals of the Agency's "cGMPs for the
21st Century" and "Critical Path Initiative" (www.fda.gov/oc/initiatives/criticalpath/)
which seek to modernise the development of new drugs.
The full text of the guidance can be found at:
http://www.fda.gov/cber/gdlns/qualsystem.pdf
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