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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.
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