Disambiguation evidence for Certificates of Suitability (CEP) via surface form
"Certificates of Suitability"
As subject (48)
Triples where this entity appears as subject under the
label "Certificates of Suitability".
| Predicate | Object |
|---|---|
| abbreviation | CEP ⓘ |
| applicationSubmittedBy | manufacturer of the substance ⓘ |
| applicationSubmittedTo |
European Directorate for the Quality of Medicines & HealthCare
ⓘ
surface form:
EDQM
|
| appliesTo | active pharmaceutical ingredients ⓘ |
| appliesTo | excipients used in medicinal products ⓘ |
| appliesTo | substances used in pharmaceutical manufacturing ⓘ |
| basedOn |
European Directorate for the Quality of Medicines & HealthCare
ⓘ
surface form:
European Pharmacopoeia monographs
|
| benefit | facilitates mutual recognition of substance quality across Europe ⓘ |
| benefit | protects confidential manufacturing information of the substance manufacturer ⓘ |
| benefit | reduces regulatory workload for national authorities ⓘ |
| containsInformationOn | compliance with specific European Pharmacopoeia monographs ⓘ |
| containsInformationOn | impurity profile of the substance ⓘ |
| containsInformationOn | manufacturing process of the substance ⓘ |
| containsInformationOn | quality control of the substance ⓘ |
| evaluationIncludes | assessment of analytical methods ⓘ |
| evaluationIncludes | assessment of impurity controls ⓘ |
| evaluationIncludes | 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 ⓘ |
| instanceOf | European Pharmacopoeia certificate ⓘ |
| instanceOf | pharmaceutical regulatory document ⓘ |
| issuedBy |
European Directorate for the Quality of Medicines & HealthCare
ⓘ
surface form:
EDQM
|
| issuedBy | 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 ⓘ |
| purpose | demonstrate compliance of a substance with European Pharmacopoeia standards ⓘ |
| purpose | simplify marketing authorisation applications for medicinal products ⓘ |
| purpose | streamline use of substances in pharmaceutical products across Europe ⓘ |
| recognizedBy | European Medicines Agency ⓘ |
| recognizedBy | European medicines regulatory authorities ⓘ |
| recognizedBy | national competent authorities in Europe ⓘ |
| regulatoryScope | quality of active substances ⓘ |
| regulatoryScope | quality of certain starting materials ⓘ |
| regulatoryScope | quality of excipients ⓘ |
| relatedTo | European Pharmacopoeia ⓘ |
| relatedTo | active substance master file system ⓘ |
| subjectTo | inspections of manufacturing sites ⓘ |
| subjectTo | post-certification surveillance by EDQM ⓘ |
| subjectTo | revision or withdrawal in case of non-compliance ⓘ |
| usedBy | API manufacturers ⓘ |
| usedBy | pharmaceutical companies ⓘ |
| usedBy | regulatory authorities ⓘ |
| usedIn | marketing authorisation applications for medicinal products ⓘ |
| usedIn | variation applications for medicinal products ⓘ |
| validity | time-limited and subject to renewal ⓘ |