FDA Publishes Final Guidance: Quality System Approach to Pharmaceutical cGMP Regulations

 
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
  

• GMP and FDA Compliance in Quality Assurance Units to be held in Prague from
  8-10 November 2006. This event is recognised within the framework of the GMP Certification Programme (read the details at www.gmp-certification.org).

Comparison between draft and final version:
Participants in the above events receive on demand a comparison of the final version with the draft where the deleted and inserted passages are marked. When you register for one of these events, simply indicate your e-mail address and the wish to receive a copy of the comparison. Click here to view an excerpt.

 
Author:
Wolfgang Schmitt
On behalf of ECA