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

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...

The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI ...

Since the formation of the European Union (EU) in 1993, each member state has brought along its own regulatory baggage, namely the standards and regulations that their companies are formally required ...

The European Commission's revision of its Good Manufacturing Practices (GMP) Annex 1 for sterile drug products was released in August 2022, after 14 years of development. The proposed changes will be ...

Laboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific integrity or demonstrate quality assurance of manufactured products. Regulated labs ...

The World Health Organization (WHO) recently issued a revised draft guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products as well a new draft guideline ...