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Posts Tagged ‘ASTM E2500’

Continued Process Verification in the Process Validation Lifecycle

Posted in Life Sciences, Operations Management on Thursday, January 22nd, 2015. 5 comments so far
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In 2011, the U.S. Food and Drug Administration (FDA) issued a Guidance for Industry – Process Validation: General Principles and Practices. It highlighted a third validation stage goal of continued process verification (CPV) for: …continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems […]

ASTM E2500-Early, Targeted Testing Leads to Faster Implementations

Posted in Life Sciences, Regulatory Compliance on Wednesday, January 25th, 2012. No comments yet
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Last week, I highlighted Emerson’s Heather Schwalje thoughts on Continuous Process Verification per U.S. Food & Drug Administration (FDA) guidelines. In a comment, Pharmaceutical Manufacturing magazine senior editor, Paul Thomas, highlighted a great article, A Practical Roadmap to Pharmaceutical Process Validation for Pharmaceutical and Biotech manufacturers. I saw another great analysis piece by Heather on […]