Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeial General Monograph "Substances for Pharmaceutical Use" and General Chapter" Control of Impurities in Substances for Pharmaceutical Use"
Title:
Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeial General Monograph "Substances for Pharmaceutical Use" and General Chapter" Control of Impurities in Substances for Pharmaceutical Use"
Short Title:
CPMP/QWP1529/04
Origin/Publisher:
EMEA
Document Type:
CPMP Guideline
Content:
This guideline describes the process of revision for the EDQM and the licensing authorities for old monographs of pharmacopoeial substances which do not comply with today's requirements for impurities, mainly related substances.