One of the key stages delaying and increasing costs in life sciences projects is equipment validation. In fact, it is one of the elements of project completion that project teams are most eager to compress because the value of every incremental improvement is so...
Continued Process Verification in the Process Validation Lifecycle
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...
ASTM E2500-Early, Targeted Testing Leads to Faster Implementations
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...
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