GMP

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Three principles of GMP

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PIC/S GMP Annex 11 Computerized System Revision

2022.03.16

PIC/S GMP Annex 16 newly established

2022.01.23

Differences in regulatory requirements between Europe, the U.S. and Japan

2021.11.17

What is a partial amendment?

2021.10.25

Purpose of PQ

2019.01.21

Annex 15: Qualification and Validation（邦訳）

2019.01.15

Quality Systems Approach to Pharmaceutical CGMP Regulations（2006.9）

2018.12.27

サイトマスターファイル 製薬協・APAC（Asia Partnership Conference of Pharmaceutical Associations）での課題としてアジア規制当局、業界団体も調整して作成

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What is a Qualification Assessment?