Process Validation Batches
5. Does CGMP regulations require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? No. Neither the CGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process. The current FDA guidance on APIs (see guidance for industry ICH Q7 for APIs) also does not specify a specific number of batches for process validation. https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practice-regulations-production-and-process
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