Introduction To ASTM E3263-20:
By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa
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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) that describes what criteria have to be met for visual inspection to be acceptable to the EMA for release of manufacturing equipment. Some form of guidance or a standard has been needed to guide these industries on how to meet these criteria and demonstrate that operators/QA inspectors are capable and qualified to accurately assess the absence or presence of residues on manufacturing equip
PDA Announces Results of 2020 Board Election and First All-Female Executive Committee
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The 2021 PDA Board of Directors and Executive Committee
The diversity of our all-volunteer board of directors helps PDA continue to meet the needs of pharmaceutical and biopharmaceutical professions around the globe. BETHESDA, Md. (PRWEB) December 11, 2020 The Parenteral Drug Association (PDA) today announced the results of the 2020 Board of Directors Election for the term beginning January 1, 2021. Members chose from a slate of candidates to fill three director positions, as the composition of the 2021 Executive Committee was determined in the 2019 BoD election.
The 2021 Board of Directors and Executive Committee is the most diverse in PDA’s 70-year history, and features the only all-female team of Officers in the industry (winners of the 2020 election indicated in parentheses):