Transcription of 工艺变更控制策略 Control Strategy of Process Change
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工艺变更控制策略 Control Strategy of Process Change
Cont rol St rat egy of Process Change2021-03-30 MabPlex International Ltd. Your trust partner in CDMOC onfidentialConfidential 1 2 Confidential ConfidentialGMP GMP2010
Guidance for Industry CGMP for Phase 1 Investigational Drugs. E. Manufacturing and Records. A record of changes in procedures and processes used for subsequent batches along with the rationale for any changes
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