EudraLex Volume 4 – Good manufacturing Practice (GMP) guidelines

GMP compressed

Summary of contents

Part I- Basic Requirement for medicinal products
Part I has following 9 chapters:
Chapter 1: Pharmaceutical quality system
Chapter 2: Personnel
Chapter 3: Premise and Equipment
Chapter 4: Documentation
Chapter 5: Production
Chapter 6: Quality control
Chapter 7: Outsourced activities
Chapter 8: Complaint and Product Recall
Chapter 9: Self Inspection
Part II- Basic Requirements for Active Substances used as Starting Materials
Part III- GMP related documents
Part III contains following documents/guidelines and annexures:
Site Master File
Quality Risk Management
Guidance on Pharmaceutical Quality System
MRA Batch Certificate
Template for the “written confirmation” for active substances exported to the European Union for medicinal products for human use
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
Template for IMP batch release
Annex 1: Manufacture of Sterile Medicinal Products
Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use
Annex 3: Manufacture of Radiopharmaceuticals
Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 5: Manufacture of Immunological Veterinary Medicinal Products
Annex 6: Manufacture of Medicinal Gases
Annex 7: Manufacture of Herbal Medicinal Products
Annex 8: Sampling of Starting and Packaging Materials
Annex 9: Manufacture of Liquids, Creams and Ointments
Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
Annex 11: Computerised Systems
Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 13: Manufacture of Investigational Medicinal Products
Annex 14: Manufacture of Products derived from Human Blood or Human Plasma
Annex 15: Qualification and validation
Annex 16: Certification by a Qualified Person and Batch Release
Annex 17: Parametric release
Annex 19: Reference and Retention Samples
Part IV – GMP requirements for Advanced Therapy Medicinal Products
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
Other documents related to GMP
Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures
Guidelines on Good Distribution Practice of Medicinal Products for Human Use
Good Distribution Practice of active substances for medicinal products for human use

Note: Annex 18 is formed the basis of detailed guideline to create Part II of EudraLex Volume 4 GMP guide. Therefore, there is no annex 18.
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