Transcription of 工艺变更控制策略 Control Strategy of Process Change
1 Cont rol St rat egy of Process Change2021-03-30 MabPlex International Ltd. Your trust partner in CDMOC onfidentialConfidential 1 2 Confidential ConfidentialGMP GMP2010
2 Confidential WHO guidelines on the transfer of technology in pharmaceuticalmanufacturing a) I b) II RA c) III d) IV Confidential Confidential
3 ConfidentialGMP 2021 ConfidentialGMP GMP PQS Established Conditions, ECs.
4 ECs ECs ECs ECs ECs DesignSpace III II I ConfidentialGMP ICH Q12 ConfidentialGMP ICH Q12 ICH Q10 Confidential ConfidentialICH Q10 Confidential III I/II / I/II
5 / Confidential Confidential GuidanceforIndustryCGMPforPhase1 InvestigationalDrugsE.
6 ManufacturingandRecordsA record of changes in procedures and processes used for subsequent batches along with the rationale for any changes Confidential Confidential IND I/II/III PV BLA Confidential
