Validation - a New Philosophy Ahead

GMP News No. 810

GMP News
11 October 2006
 

Validation - a New Philosophy Ahead

 
In past issues of our GMP News, we illustrated the changes made by the FDA in the field of process validation.

Let us summarise the history for you:

With its "cGMPs for the 21st Century" Initiative, the FDA has begun to change the concept of process validation. To date, process validation is linked with 3 validation runs. This number goes back to the process validation guideline and to a Compliance Policy Guide (CPG) on process validation of 1993. This CPG was revised in 2004, and the revision does not mention a number of process validation runs any more. Validation is seen as a life cycle approach, for which reason the CPG does not use the term "validation runs" any longer.

Since then, several articles on process validation have been written by the industry, and the FDA has announced that it will revise the "old" process validation guideline of 1987 (!).

Interestingly, a new definition of validation can be found in the just finalised Guidance for Industry "Quality Systems Approach to Pharmaceutical CGMP Regulations".

There, the glossary says: "Validation – Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled". As a reference, it gives "The ASQ Auditing Handbook", 3rd edition, ASQ Quality Audit Division, J.P. Russell, (Editor). Just like the above CPG, this new guidance does not mention a concrete number of validation runs. It does not refer to the "old" FDA process validation guideline either, even though it still lists that guideline among the "helpful reference materials".

Once more, this underlines the present development towards a more scientific background for defining the appropriate number of validation runs.

It is to be hoped that the revision of the validation guideline will clarify the situation.
  

The traditional and the new approach to validation are the focus of the 3-day intensive seminar

This seminar is recognised for the GMP Certification Programme. Find more information at

www.gmp-certification.org

Author:
Sven Pommeranz
On behalf of ECA

The Guidance for Industry "Quality Systems Approach to Pharmaceutical CGMP Regulations" can be found here

http://www.fda.gov/cber/gdlns/qualsystem.htm
   

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