Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
(Previously ARGPM Appendix 11: Drug Master Files and Certificates of Suitability)
This guidance is intended for manufacturers of drug substances for prescription medicines, and sponsors of prescription medicines sourcing drug substances from a third party manufacturer.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Office of Medicines Authorisation||09/08/2013|