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FDA Draft Process Validation Guidance, An Industry Perspective
This article, which recently won the 2009 Pharmaceutical Engineering ARTICLE OF THE YEAR Award, provides an overview of the draft guidance, the key changes in relation to the 1987 guidance, and a review of its potential impact on current industry approaches to science - and risk-based design and qualification activities which support the process validation programme.
An article was written by Alice Redmond and Nuala Calnan of PM Group and Stan O'Neill (The Compliance Group).
Click the link to read the full PDF article:
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