- Good Manufacturing Practice (GMP)
- ALCOA Principles
- Pharmaceutical Quality System
- Quality Control (QC) Methods for Advanced Therapy Medicinal Products (ATMPs)
- ISO 9000 family
- U.S. Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- EudraLex Volume 4
- EudraLex Volume 4 – Annex 1: Manufacture of Sterile Medicinal Products
- EudraLex Volume 4 – Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use
- EudraLex Volume 4 – Annex 3: Manufacture of Radiopharmaceuticals
- EudraLex Volume 4 – Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
- EudraLex Volume 4 – Annex 5: Manufacture of Immunological Veterinary Medicinal Products
- EudraLex Volume 4 – Annex 6: Manufacture of Medicinal Gases
- EudraLex Volume 4 – Annex 7: Manufacture of Herbal Medicinal Products
- EudraLex Volume 4 – Annex 8: Sampling of Starting and Packaging Materials
- EudraLex Volume 4 – Annex 9: Manufacture of Liquids, Creams and Ointments
- EudraLex Volume 4 – Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
- EudraLex Volume 4 – Annex 11: Computerised Systems
- EudraLex Volume 4 – Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
- EudraLex Volume 4 – Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma
- EudraLex Volume 4 – Annex 15: Qualification and Validation
- EudraLex Volume 4 – Annex 16: Certification by a Qualified Person and Batch Release
- EudraLex Volume 4 – Annex 17: Real Time Release Testing and Parametric Release
- U.S. FDA 21 CFR Part 210
- U.S. FDA 21 CFR Part 211
- U.S. FDA 21 CFR Part 212
- U.S. FDA 21 CFR Part 314
- ICH Q7
- ICH Q10
- Regulatory Guidelines for Advanced Therapy Medicinal Products (ATMPs)
- U.S. Food and Drug Administration (FDA)
