PIC/S Guide to Good Manufacturing Practice for Medicinal Products
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16) Introduction
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16) Part I
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16) Part II
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16) Annexes
Read also: List of PICS GMP Guide (Annexes)
EudraLex Volume 4 - Good Manufacturing Practices - Medicinal Products for Human and Veterinary use
Part I - Basic GMP Requirements for Medicinal Products
- EU GMP Chapter 1: Pharmaceutical Quality System
- EU GMP Chapter 2: Personnel
- EU GMP Chapter 3: Premises and Equipment
- EU GMP Chapter 4: Documentation (Revision January 2011)
- EU GMP Chapter 5: Production
- EU GMP Chapter 6: Quality Control
- EU GMP Chapter 7: Outsourced Activities
- EU GMP Chapter 8: Complaints, Quality Defects and Product Recall
- EU GMP Chapter 9: Self Inspection
Part II - Basic GMP Requirements for Active Substances used as Starting Material..
Part III - GMP related documents
Part IV - GMP Requirements for Advanced Therapy Medicinal Products
EU GMP Annexes
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products
- EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use
- EU GMP Annex 3: Manufacture of Radiopharmaceuticals
- EU GMP Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological products
- EU GMP Annex 5: Manufacture of Immunological Veterinary Medicinal Products
- EU GMP Annex 6: Manufacture of Medicinal Gases
- EU GMP Annex 7: Manufacture of Herbal Medicinal Products
- EU GMP Annex 8: Sampling of Starting and Packaging Materials
- EU GMP Annex 9: Manufacture of Liquids, Creams and Ointments
- EU GMP Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations fo ...
- EU GMP Annex 11: Computerised Systems
- EU GMP Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Produ ...
- EU GMP Annex 13: Investigational Medicinal Products
- Detailed Commission guidelines on good manufacturing practice for investigationa ...
- EU GMP Annex 14: Manufacture of Products derived from Human Blood or Human Plasm ...
- EU GMP Annex 15: Qualification and Validation
- EU GMP Annex 16: Certification by a Qualified Person and Batch Release
- EU GMP Annex 17: Real Time Release Testing and Parametric Release
- EU GMP Annex 19: Reference and Retention Samples
