US GMPs
Background:
References:
- Code of Federal Regulations (US GMP’s)
- 21 CFR 58 – Good Labratory Practices for Non-Clinical Laboratory Studies
- 21 CFR Parts 210 – Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General
- 21 CFR 211 – Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; Current Good Manufacturing Practice For Finished Pharmeceuticals
- 21 CFR 600 – Biologic Products: General
- 21 CFR 601 – Licensing
- 21 CFR 610 – General Biological Products Standards
- 21 CFR 820 – Quality System Regulation
- Guidance for Industry: CGMP for Phase 1 Investigational Drugs
EU GMPs
Background:
References:
EUDRALEX: Volume 4–Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice
Includes:
- Annex 1: Manufacture of Sterile Medicinal Products
- Revised Annex 1 (Implementation by Mar 2010)
- Annex 2: Manufacture of Biological Medicinal Products for Human Use
- Annex 8: Sampling of Starting and Packaging Materials
- Annex 11: Computerised Systems
- 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 19: Reference and Retention Samples
- Annex 20: Quality Risk Management
ICH
World Health Organization (WHO)
- Quality assurance of pharmaceuticals
- Good Manufacturing Practices for pharmaceutical products: main principles (Technical Report)
- Annex 2; Good manufacturing practices: requirement for the sampling of starting materials (amendment). Pg 47
- Good manufacturing practices for Biological Productss pg 26
