CEP

E386102

Certificate of Suitability pharmaceutical quality certificate

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

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All labels observed (1)

Label	Occurrences
CEP canonical	1

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 ⓘ surface form: European Pharmacopoeia monographs European Pharmacopoeia standards ⓘ
basisOfAssessment	European Pharmacopoeia ⓘ surface form: 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	Certificates of Suitability to the monographs of the European Pharmacopoeia ⓘ surface form: Certificate of Suitability to the monographs of the European Pharmacopoeia
issuedBy	European Directorate for the Quality of Medicines & HealthCare ⓘ surface form: 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 ⓘ

Referenced by (1)

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

Certificates of Suitability (CEP) → abbreviation → CEP ⓘ

subject surface form: Certificates of Suitability