How can conformance with GMP requirements for active substances be proven?
European medicinal product manufacturers are obliged to use as starting materials only active substances that have been manufactured in compliance with EU GMP requirements. This proof is provided by EU GMP certificates, GMP certificates from authorities in third countries with a mutual recognition agreement (MRA and ACAA) and written confirmations from authorities in third countries.
[GMP Compliance Adviser, Chapter 20.D]
Would you like to discover more?
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
