Certificates of Suitability (CEP)
E82718
Certificates of Suitability (CEP) are official documents that certify a substance’s compliance with European Pharmacopoeia standards, streamlining its use in pharmaceutical products across Europe.
Aliases (1)
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
European Pharmacopoeia certificate
→
pharmaceutical regulatory document → |
| abbreviation |
CEP
→
|
| applicationSubmittedBy |
manufacturer of the substance
→
|
| applicationSubmittedTo |
EDQM
→
|
| appliesTo |
active pharmaceutical ingredients
→
excipients used in medicinal products → substances used in pharmaceutical manufacturing → |
| basedOn |
European Pharmacopoeia monographs
→
|
| benefit |
facilitates mutual recognition of substance quality across Europe
→
protects confidential manufacturing information of the substance manufacturer → reduces regulatory workload for national authorities → |
| containsInformationOn |
compliance with specific European Pharmacopoeia monographs
→
impurity profile of the substance → manufacturing process of the substance → quality control of the substance → |
| evaluationIncludes |
assessment of analytical methods
→
assessment of impurity controls → assessment of manufacturing documentation → |
| format |
unique certificate number identifying the substance and holder
→
|
| fullName |
Certificates of Suitability to the monographs of the European Pharmacopoeia
→
|
| holder |
company to which the CEP is granted
→
|
| issuedBy |
EDQM
→
European Directorate for the Quality of Medicines & HealthCare → |
| jurisdiction |
Council of Europe
→
|
| language |
issued in English or French
→
|
| legalStatus |
voluntary alternative to full substance documentation in marketing authorisation dossiers
→
|
| purpose |
avoid duplication of quality assessments by national authorities
→
demonstrate compliance of a substance with European Pharmacopoeia standards → simplify marketing authorisation applications for medicinal products → streamline use of substances in pharmaceutical products across Europe → |
| recognizedBy |
European Medicines Agency
→
European medicines regulatory authorities → national competent authorities in Europe → |
| regulatoryScope |
quality of active substances
→
quality of certain starting materials → quality of excipients → |
| relatedTo |
European Pharmacopoeia
→
active substance master file system → |
| subjectTo |
inspections of manufacturing sites
→
post-certification surveillance by EDQM → revision or withdrawal in case of non-compliance → |
| usedBy |
API manufacturers
→
pharmaceutical companies → regulatory authorities → |
| usedIn |
marketing authorisation applications for medicinal products
→
variation applications for medicinal products → |
| validity |
time-limited and subject to renewal
→
|
Referenced by (1)
| Subject (surface form when different) | Predicate |
|---|---|
|
European Directorate for the Quality of Medicines & HealthCare
→
|
issues |