Transcription of 2017 GMP事例研究会 - jpma.or.jp
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2017 GMP事例研究会 - jpma.or.jp
2017 GMP BMS data integrity BMS 1 data integrity : WHY NOW? BMS data integrity : BMS data integrity : Assessment 2 BMS data integrity 1960 6 113 4,000 2016 1,650 2017 4 3 -A 4 data integrity : WHY NOW? 5 data integrity : WHY NOW? data integrity MHRA GMP data integrity Definitions and Guidance for Industry March 2015 FDA: data integrity and Compliance With cGMP- Guidance for Industry (Draft April 2016) MHRA GxP data integrity Definitions and Guidance for Industry (Draft version for consultation July 2016) WHO Annex 5-Guidance on good data and record management practices (draft July 2016) EMA data integrity Guidance (Aug 2016) PIC/S Good Practices for data Management and integrity in Regulated GMP/GDP Environments (draft Aug 2016) 6 data integrity : WHY NOW?
2017年度GMP事例研究会. BMS愛知工場における Data Integrityの取り組み事例 BMS K.K. 愛知工場 ｸｵﾘﾃｨｵﾍﾟﾚｰｼｮﾝ 品質保証 杉浦 昇 1
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