The European Commission has set forth requirements for quality assurance in production processes and environments in the principles of Good Manufacturing Practice (GMP) for medicinal products for human use to ensure process verification. Detailed guidelines for interpreting these GMP principles can be found in the EU GMP Guide:
- EU GMP Guide Part I: Guide to Good Manufacturing Practice.
- EU GMP Guide Part II: Basic requirements for active substances used as starting materials.
- EU GMP Guide Part III : GMP-related documents.
- EU GMP Guide Part IV: GMP requirements for advanced therapy medicinal products.