CEP

E386102

CEP is the commonly used abbreviation for Certificates of Suitability, which attest that a pharmaceutical substance complies with European Pharmacopoeia standards.

All labels observed (1)

Label Occurrences
CEP canonical 1

How this entity was disambiguated

Statements (46)

Predicate Object
instanceOf Certificate of Suitability ⓘ
pharmaceutical quality certificate ⓘ
abbreviation CEP ⓘ
appliesTo TSE risk materials ⓘ
biological substances ⓘ
chemical substances ⓘ
herbal substances ⓘ
attestsComplianceWith European Pharmacopoeia monographs ⓘ
European Pharmacopoeia standards ⓘ
basisOfAssessment European Pharmacopoeia monograph requirements ⓘ
Good Manufacturing Practice information ⓘ
benefit avoids duplication of quality assessment in each country ⓘ
harmonizes quality standards across Europe ⓘ
containsInformationOn analytical methods ⓘ
impurity profile ⓘ
manufacturing route ⓘ
specifications of the substance ⓘ
documentType quality assessment document ⓘ
regulatory certificate ⓘ
fullForm Certificate of Suitability to the monographs of the European Pharmacopoeia ⓘ
issuedBy EDQM ⓘ
European Directorate for the Quality of Medicines & HealthCare ⓘ
jurisdiction Council of Europe member states ⓘ
European pharmaceutical market ⓘ
language English ⓘ
French ⓘ
purpose demonstrate compliance with European Pharmacopoeia monographs ⓘ
simplify regulatory assessment of substance quality ⓘ
support marketing authorization applications ⓘ
regulatoryScope control of impurities ⓘ
manufacturing process consistency ⓘ
quality of pharmaceutical substances ⓘ
relatedTo European Pharmacopoeia ⓘ
active substance master file ⓘ
marketing authorization dossier ⓘ
subjectTo renewal ⓘ
revision ⓘ
suspension ⓘ
withdrawal ⓘ
usedBy marketing authorization holders ⓘ
pharmaceutical manufacturers ⓘ
regulatory authorities ⓘ
usedFor active pharmaceutical ingredients ⓘ
excipients ⓘ
pharmaceutical substances ⓘ
validity time-limited ⓘ

How these facts were elicited

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

Certificates of Suitability → abbreviation → CEP ⓘ