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 |
Annexes |
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 |