The European Union has now issued the good manufacturing practice (GMP) guidance for on investigational medicinal products (IMPs) for human use. The EU GMP guidelines on investigational medicinal ...

An overview of the validation and qualification requirements introduced in the 2022 EU GMP Annex 1 revision, with a focus on ...

智通财经APP讯，博腾股份(300363.SZ)发布公告，公司全资子公司上海博腾智拓医药科技有限公司(以下简称“博腾智拓”)于近日获得欧盟质量受权人(Qualified Person, QP)签发的符合性声明，顺利通过欧盟QP审计。 本次审计依据 EU GMP Guidelines EudraLex Volume 4、EU Clinical Trial ...

欧盟GMP认证是指符合欧洲药品管理局（EMA）颁布的《药品生产质量管理规范》（EU GMP Guidelines）标准的企业所获得的认证。 通过欧盟GMP认证不仅是对制药企业的生产实力的认可，同时也是对其产品质量可信赖的认可。值得一提的是，先声药业旗下止泻药品牌 ...

The European Commission has published a set of guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products (ATMPs). ATMPs are medicines for human use that are based ...

Dublin, June 20, 2024 (GLOBE NEWSWIRE) -- The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" conference has been added to ...

COLOGNE, Germany--(BUSINESS WIRE)--Cannamedical® Pharma GmbH (Cannamedical), the leading German independent cannabis importer, signed three new supply agreements with Canadian producers of medical ...