Search results for " cpv"
Article
Continued Process Verification for Biopharma Manufacturing
Guidance issued by FDA in 2011 (1) emphasized the importance of manufacturers undertaking CPV as an integral part of the process validation lifecycle. CPV will provide the manufacturer with assurance …
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
One strategy is to apply wider criteria (50% confidence) to a smaller number of PPQ lots with monitoring of a larger number of CPV (Stage 3) lots to meet the target statistical criteria (95% confidenc…
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Automating Bioprocesses
Companies have been moving towards CPV rather than annual product reviews. Requirements are emerging, particularly for biopharmaceuticals, to provide CPV across all manufacturing locations for a produ…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
A good CPV program assures the process is under control and that any process drift in performance is detectable and can be proactively addressed.
Breaking Down the Critical Parts of Criticality …
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…