domain
製藥
(5 項標準)行業: 製藥
GMP (cGMP)Active
GMP (cGMP)
Good Manufacturing Practice — WHO Guidelines & FDA 21 CFR 210/211
全球美國
ICH E6(R3)Final ICH Step 4 — regional implementation varies
ICH E6(R3)
Good Clinical Practice for clinical trials involving human participants
全球歐盟美國英國加拿大日本中國
ISO 37301:2021Active
ISO 37301:2021
Compliance management systems — Requirements with guidance for use
全球
ISO 35001:2019Active
ISO 35001:2019
Biorisk management for laboratories and other related organisations
全球
EU CLP RegulationActive
EU CLP Regulation
Classification, Labelling and Packaging of Substances and Mixtures — Regulation (EC) No 1272/2008
歐盟歐洲經濟區