| 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 |
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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 |
