EDQM FAQs
General and scope
- What does ‘CEP’ mean?
- How to use a CEP?
- Is CEP mandatory for marketing a substance in EU countries?
- How should the certificate coding be interpreted?
- How do I know if I have the latest valid version of a CEP?
- Can I get a copy of a certificate from the EDQM?
- Does the Certification procedure apply to herbal drugs and herbal drug preparations?
- How long does it take to obtain a certificate of suitability?
- Which countries accept certificates of suitability?
- Is a certificate of suitability equivalent to a GMP certificate?
- Is it possible to apply for a CEP for biological substances?
- How can I withdraw my CEP?
- What does “P0X” or “PXX” mean as an extension to the CEP number on EDQM CEP communication letters (Re: CEP 202X-XXX-P0X or PXX / Substance name)?
Quality Overall Summary (QOS)
- How should the Quality Overall Summary (QOS) be prepared?
- What does the QOS consist of?
- Who has to write the QOS? Can the expert be a person from the manufacturing company?
Application dossier
- Are alternative methods accepted?
- Are analytical procedures appended to a CEP considered equivalent to a European Pharmacopoeia monograph method?
- Can some tests be omitted?
- Should all tests referred to in a CEP be performed for routine analysis/batch release?
- Is a certificate of suitability equivalent to a certificate of analysis?
- How should I deal with different grades of the same substance?
- How should I deal with recovery of materials in a dossier?
- Does skip testing need to be declared in CEP application dossier?
- What should we do if we use peptones in the manufacture an active substance?
- 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?
- In our CEP application, is it possible to claim that the quality of our substance complies with a specific degree of hydration when degree of hydration is not defined in the corresponding individual Ph. Eur. monograph?
- In the revised Ph. Eur. monograph, a degree of hydration has been either removed from / clarified in the title of the substance. Will EDQM issue a new certificate of suitability to reflect this?
Sterile substances
- Is it possible to apply for CEPs for sterile substances?
- Which GMPs should apply to the sterilisation step of a substance?
TSE
- Which types of material require a TSE risk assessment?
- I am applying for a “double” CEP, where should I include the TSE information in the application if this is not covered by a CEP?