This was the guidance in the original "Guideline for Process Validation",
where it stated that a minimum of three batches was required for validation.
Everyone seems to forget the word "minimum".
In 2004 this was superseded by a Compliance Policy Guide that that stated
that the number of validation batches required depended on the company's
degree of knowledge of the process. The number of validation batches (now
referred to as conformance batches) could be anywhere from 1 (where there
was a great deal of process knowledge from development and previous
experience), to any number (say 17, or 207, pick your number depending on
your degree of process knowledge)
With Best Regards,
Michael Anisfeld
Globepharm
e-mail: manisfeld@globepharm.org
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