EMA - 3-year work plan for the Quality domain

17th May 2023

EMA

EMA have developed a 3-year work plan for the Quality domain

Activities include:

• GMP Guide: Chapter 4 (Documentation)
• GMP Guide: Annex 11 (Computerised Systems)
• Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
• GMP Guide: Annex 15 Qualification and Validation
• GMP Guide: Annex 16 Certification by a Qualified Person and Batch Release
• GMP Guide: Annex 4 (Manufacture Of Veterinary Medicinal Products Other Than Immunological Veterinary Medicinal Products)
• GMP Guide: Annex 5 (Manufacture Of Immunological Veterinary Medicinal Products)
• GMP Guide: GMP for Novel Veterinary Medicinal Products
• GMP Guide: GMP for Autogenous Veterinary Vaccines.
• ICH Q9: Quality Risk management
• GMP and Marketing Authorisation Holders
• ICH Q12: Lifecycle management
• ICH Q7: GMP for Active Substances
• ICH Q13: Continuous Manufacturing
• VICH: GMP for API’s for Veterinary Medicines
• VICH: Other Q Guidelines for Veterinary Medicines
• Implementing Act: GMP for Veterinary Medicinal Products
• Implementing Act: GMP for active substances for Veterinary Medicinal Products
• Input into International activities (beyond (V)ICH guidelines)

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