GMP Regulatory Reference
CFR: Code of Federal Regulations Title 21
CFR: Code of Federal Regulations Title 21
Part I – Basic Requirements for Medicinal Products
- Chapter 1 Pharmaceutical Quality System
- Chapter 2 Personnel
- Chapter 3 Premise and Equipment
- Chapter 4 Documentation (January 2011)
- Chapter 5 Production
- Chapter 6 Quality Control
- Chapter 7 Contract Manufacture and Analysis
- Chapter 7 on Outsourced activities
- Chapter 8 Complaints and Product Recall
- Chapter 9 Self Inspection
Part II – Basic Requirements for Active Substances used as Starting Materials
Part III – GMP related documents
- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients
- of medicinal products for human use
- MRA Batch Certificate
- Q9 Quality Risk Management
- Q10 Note for Guidance on Pharmaceutical Quality System
- Site Master File
- Template for the ‘written confirmation’ for active substances exported to the European Union for medicinal products for human use
EUDRALEX 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 (revision January 2011)
- 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 – current
- Annex 16 Certification by a Qualified person and Batch Release
- Annex 17 Parametric Release
- Annex 19 Reference and Retention Samples
CFDA – China Food and Drug Administration
PICS – The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
Health Canada
Health Canada – Good Manufacturing Practices (GMP) Guidelines – 2009 Version 2
WHO – World Health Organization
- WHO good manufacturing practices for pharmaceutical products – main principles
- WHO good manufacturing practices for active pharmaceutical ingredients – Annex 2
- WHO good manufacturing practices for biological products – Annex 3
- WHO good manufacturing practices for blood establishments – Annex 4
- WHO Good Manufacturing Practices Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients Annex 5
- WHO good manufacturing practices for sterile pharmaceutical products Annex 6
- WHO Good Manufacturing Practices Supplementary Guidelines for the Manufacture of investigational Pharmaceutical Products for clinical trials in
- Human Annex 7
- WHO good manufacturing practices for pharmaceutical products containing hazardous substances
- WHO good manufacturing practices water for pharmaceutical use
- WHO Guidelines on Good Manufacturing Practices for radiopharmaceutical products
- WHO Supplementary guidelines on good manufacturing practices for the manufacture of herbal medicine
- Supplementary guidelines on good manufacturing practices – Validation
- Supplementary guidelines on good manufacturing practices for heating, ventilation and air conditioning for non-sterile pharmaceutical dosage form
- WHO Application of Hazard Analysis and Critical Control Point (HACCP) methodology to Pharmaceuticals