Transcription of ICH Q7 API GMP Guide - gmpeye.co.kr
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ICH Q7 API GMP Guide - gmpeye.co.kr
ICH GMP Guide for Active Pharmaceutical Ingredients GI001A gggmmmpppeeeyyyeee 42 (Batch Production Record Review) Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labelling, to determine compliance of the intermediate or API with established specifications before a batch is released or distributed. , API , . Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed.
ICH GMP Guide for Active Pharmaceutical Ingredients GI001A ggmmppeeyyee www.gmpeye.co.kr 43 quarantine, storage, handling, sampling, testing, and approval or …
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