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 FDAin the field of process validation.

Let us summarise the history for you:

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

Since then, several articles on process validation have been written bythe 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 justfinalised Guidance for Industry "Quality Systems Approachto Pharmaceutical CGMP Regulations".

There, the glossary says: "Validation – Confirmation, through theprovision of objective evidence, that the requirements for a specificintended 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 notmention a concrete number of validation runs. It does not refer to the"old" FDA process validation guideline either, even though it still liststhat guideline among the "helpful reference materials".

Once more, this underlines the present development towards a morescientific background for defining the appropriate number of validationruns.

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

The traditional and the new approach to validation are thefocus of the 3-day intensive seminar
  • The Validation Managerin Barcelona, Spain, from 30 January to 2 February 2007

This seminar is recognised for the GMP Certification Programme.

Sven Pommeranz
On behalf of ECA

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

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