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The pharma industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Due to...
Introduction To ASTM E3263-20: By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa Part of the series Visual inspection has been widely used for many years by the pharmaceutical, biologics, and medical device industries after cleaning to release manufacturing equipment and devices. However, visual inspection has never been demonstrated to be an effective, reliable, or safe method to use for these inspections. Recently, the European Medicines Agency (EMA) issued a Q&A 1 to its guideline on determining health-based exposure limits (HBELs...