ABSTRACT
The need for process validation may seem obvious to the
technically oriented. Validation is the essential “proof of
the pudding”; an attestation that the process in question
can be depended upon to consistently produce a drug
product of stipulated quality and purity. The scientific
exercise focuses upon the surety of drug identity and the
reliability of its manufacture. Dependability, reliability,
consistency, certainty and other virtues as well are seen
as the accompaniments of the validation practice. Given
what now seems so obvious a requirement, it may be
puzzling to some that it took years to develop the concept
as posed by the FDA and as modified and accepted in
concert with the pharmaceutical industry. The history of
this development has been detailed most helpfully (1).
