Glossary

CMC–PHARMAPILOT

Strategy | Science | Service

Glossary

CMC Chemistry, Manufacturing, Control
eCTD electronical Common Technical Document
ASMF Active Substance Master File
DMF Drug Master File
CEP Certification of Suitability to the Monographs of the European Pharmacopoeia
GMP Good Manufacturing Practice
QC Quality Control
QA Quality Assurance
QM Quality Management
API Active Pharmaceutical Ingredient
NCE New Chemical Entity
MRT Magnetic Resonance Tomography
CT Computer Tomography
MoA Method of Analysis
EDQM European Directorate for the Quality of Medicines & HealthCare (edqm.eu)
FDA U.S. Food and Drug Administration (fda.gov)