European (EU) Guidelines

European Medicines (Eudralex: Applicable to all EU Countries)

Current Members: Following are the current members of the European Medicines.

United Kingdom, Cyprus, Italy, Czech Rep, Belgium, Slovenia, Denmark, Liechtenstein, France, Germany, Norway, Greece, Spain, Hungary, Iceland, Austria, Ireland, Latvia, Portugal, Lithuania, Estonia, Luxembourg, Netherlands, Poland, Romania, Slovakia, Malta, Sweden, Finland.

Part I - Basic Requirements for Medicinal Products

• Chapter 1 Pharmaceutical Quality System (65 KB)
• Chapter 1 Quality Management (revision February 2008)(29 KB)
• Chapter 2 Personnel(20 KB)
• Chapter 3 Premise and Equipment(34 KB)
• Chapter 4 Documentation (Revision January 2011) (33 KB) NEW 
• Chapter 5 Production(50 KB)
• Chapter 6 Quality Control (33 KB)
• Chapter 7 on Outsourced activities(21 KB)
• Chapter 7 Contract Manufacture and Analysis(22 KB)
• Chapter 8 Complaints and Product Recall (18 KB)
• Chapter 9 Self Inspection(11 KB)

Part II - Basic Requirements for Active Substances used as Starting Materials

• Basic requirements for active substances used as starting materials(452 KB)

Part III - GMP related documents

• Site Master File (33 KB)
• Q9 Quality Risk Management
• Q10 Note for Guidance on Pharmaceutical Quality System
• MRA Batch Certificate (101 KB)
• Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use (487 KB)(Version 2, January 2013) 
• Manufacture of Sterile Medicinal Products
• Sampling of Starting and Packaging Materials
• Manufacture of Liquids, Creams and Ointments
• Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
• Qualification and validation 
• Certification by a Qualified person and Batch Release
• Reference and Retention Samples
• EU National Competent Authorities
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)
• Active substance-master-file procedure
• Summary of requirements for active substances in the quality part of the dossier
• Chemistry of new active substances
• Investigation of chiral active substances
• Chemistry of active substances
• Process validation
• Annex II: Process Validation - Non-Standard Processes
• Manufacture of the Finished Dosage Form
• Annex: Start of Shelf-Life of the Finished Dosage Form
• Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products
• The use of Ionizing Radiation in the Manufacture of Medicinal Products
• Setting specifications for related impurities in antibiotics
• Specification Limits for Residues of Metal Catalysts
• Limits of genotoxic impurities
• Control of Impurities of Pharmacopoeial Substances
• Impurities in New Medicinal Products
• Impurities Testing: Impurities in New Drug Substances
• Impurities: Residual Solvents
• Impurities: Guideline for residual solvents
• Annexes to Specifications for class 1 and class 2 residual solvents in active substances
• Real Time Release Testing
• Specifications and control Tests on the Finished Product
• Quality of Water for Pharmaceutical Use
• Stability Testing of Existing Active Ingredients and Related Finished Products
• Stability Testing for Applications for Variations to a Marketing Authorisation
• Development Pharmaceutics
• Pharmaceutical Quality of Inhalation and Nasal Products
• Quality of Modified Release Products A) Oral Solid Dosage Forms B) Transdermal Dosage Forms Section I (Quality)