Certificate of Suitability (CEP)
A Certificate of Suitability issued by EDQM confirming that the quality of a substance, typically an API or excipient, is suitably controlled by the relevant European Pharmacopoeia monograph. It is based on assessment of the manufacturer's dossier and may follow an inspection. Applicants in Ph. Eur. member states and several other markets can use a CEP in place of detailed substance data.
Related terms
API (Active Pharmaceutical Ingredient)
An Active Pharmaceutical Ingredient is the substance in a medicine that produces its therapeutic effect. APIs…
Drug Master File (DMF)
A Drug Master File is a confidential submission to a regulator, most often the US FDA, that describes how a s…
EP / Ph. Eur. (European Pharmacopoeia)
The European Pharmacopoeia, published by EDQM of the Council of Europe and legally binding in the states that…
Pharmacopoeia
An official book of quality standards for medicines and their ingredients, with legal status in the countries…
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