What FDA Process Validation Guidance - Lifecycle Approach 2011 requires
FDA's 2011 Process Validation guidance establishes a lifecycle approach in three stages - process design, process qualification, and continued process verification - requiring manufacturers to collect and evaluate data to ensure a process consistently produces product meeting specifications.
Pillar: Biotech & Genomics · Authority: US Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) · Version: 2011-01 · Last updated:
Primary source: https://www.fda.gov/media/71021/download
SHA-256 integrity: 596989c9de976eeef8ad2b26eaba1da56c6299b41bf4914103365ec8fd68f1e2
Primary Citations — 6 traced to source
- {"title":"FDA Guidance for Industry: Process Validation - General Principles and Practices (January 2011)","url":"https://www.fda.gov/media/71021/download","section":"Sections IV.A, IV.B, IV.C - Three-Stage Lifecycle Approach","instrument_type":"FDA Guidance Document"}
- {"title":"FDA 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals","url":"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211","section":"211.100 Written procedures; deviations; 211.110 Sampling and testing of in-process materials","instrument_type":"Federal Regulation"}
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