Title: Application dossier  
Author: ZHATKIN Yurii Jul 09, 2019
Last Changed by: ZHATKIN Yurii Jul 15, 2019
Tiny Link: (useful for email) https://faq.edqm.eu/x/CQMV
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Parent Page
    Page: General information on Substances for pharmaceutical use
Children (12)
    Page: Are alternative methods accepted?
    Page: Are analytical procedures appended to a CEP considered equivalent to a European Pharmacopoeia monograph method?
    Page: Can some tests be omitted?
    Page: Should all tests referred to in a CEP be performed for routine analysis/batch release?
    Page: Is a certificate of suitability equivalent to a certificate of analysis?
    Page: How should I deal with different grades of the same substance?
    Page: How should I deal with recovery of materials in a dossier?
    Page: Does skip testing need to be declared in CEP application dossier?
    Page: What should we do if we use peptones in the manufacture an active substance?
    Page: Is it possible to apply for a Chemical CEP with reference to a specific polymorphic form when no statement on polymorphism is included in the corresponding individual Ph. Eur. monograph?
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Recent Changes
Time Editor  
Jul 15, 2019 16:47 ZHATKIN Yurii View Changes
Jul 09, 2019 16:19 ZHATKIN Yurii