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

 
On 29 September, the FDA issued the final Guidance on Quality Systems tofacilitate the modernisation of drug manufacturing. It is somehowsurprising how quickly this guidance was finalised. And it underlines howimportant this topic is to the FDA. Harmonisation efforts with ICH Q10cannot be seen in this document.

When comparing the final guidance with the draft document, one can seethat mostly changes in the wording have been made. Nevertheless, in somecases 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 expectationsare regarding the Quality System. In the case of validation, the FDAmentions the ASQ document (The ASQ Auditing Handbook, 3rd edition, ASQQuality Audit Division, J.P. Russel, Editor) and not the "old" FDA ProcessValidation 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, QualityRisk Management and a CAPA system in their expectations. "This guidanceincorporates modern quality principles into FDA's approach tomanufacturing, encouraging industry adoption of new technological advancesand integrated quality systems." said Dr Janet Woodcock, FDA DeputyCommissioner for Operations.

This document contributes to the goals of the Agency's "cGMPs for the21st 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
  

 
Author:
Wolfgang Schmitt
On behalf of ECA