EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

EudraLex Volume 4, “The Rules Governing Medicinal Products in the European Union – EU Guidelines to Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use”, provides core interpretative guidance on good manufacturing practice (GMP) in the European regulatory system. It sets detailed expectations for pharmaceutical quality systems, facilities, personnel, documentation and quality control across the lifecycle of medicinal products, and includes specific provisions for investigational medicinal products (IMPs) used in clinical trials. This makes it a key reference for investigator initiated clinical studies involving IMP manufacture, packaging, labelling, importation and release.

The Volume 4 web page is a single overview page that provides:

• a short description of the legal basis and scope of GMP guidance
• clear lists of applicable legal acts and implementing regulations
• structured links to Parts I–IV, annexes and GMP related documents, each available as a separate downloadable file.
   

From this page, users can navigate to:

• Part I: basic GMP requirements for medicinal products for human use, in chapters such as Pharmaceutical Quality System, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourced Activities, Complaints and Product Recall, Self inspection
• Part II: basic GMP requirements for active substances used as starting materials
• Part III: GMP related documents, including Site Master File guidance, quality risk management (International Council for Harmonisation Q9), pharmaceutical quality system (International Council for Harmonisation Q10), mutual recognition agreement batch certificate templates, guidance on health based exposure limits, excipient risk assessment
• Part IV: GMP requirements for advanced therapy medicinal products (ATMPs)
• Annexes: technical annexes, including Annex 1 on sterile medicinal products, Annex 13 on investigational medicinal products, and other annexes covering specific dosage forms, technologies or processes.
   

The site also links to other regulatory documents relevant to GMP and good distribution practice (GDP), including templates for written confirmation for active substances exported to the European Union, guidance on health based exposure limits and selected questions and answers on GMP/GDP. 

A practical way for new users to start is to:

• review the EudraLex Volume 4 overview page to understand the legal basis and identify which Parts and annexes apply (for example Part I and Annex 13 for human IMPs)
• download the relevant Part and annexes as PDF documents and integrate their requirements into standard operating procedures, quality management systems and IMP related trial documentation.