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European (EU) Guidelines

Learn updated guidelines developed by European Medicines Agency and European Commission.
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
Part II - Basic Requirements for Active Substances used as Starting Materials
Part III - GMP related documents

  • 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)

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