AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

CEP

 
What is the Full form of abbreviation, CEP?
Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs
It is also informally referred to as Certificate of Suitability (COS)
What is a CEP?
It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.
For which substances, applications for the grant of CEPs can be submitted?
Applications for the grant of CEPs can be submitted to EDQM if monograph (general monograph and/or specific monograph) has been adopted by the European Pharmacopoeia for the following-
  • Organic or inorganic substances (active or excipients), manufactured or extracted.
  • Sterile Active Substances
  • Substances produced by fermentation as indirect gene products, which are metabolites of microorganisms, irrespective of whether or not the microorganisms have been modified by traditional procedures or r-DNA technology
  • Products with risk of transmitting agents of animal spongiform encephalopathies (TSE)
  • Herbal Drugs and Herbal Drug Preparations
For which substances CEP is not granted?
  • Direct gene products (proteins)
  • Products obtained from human tissues
  • Vaccines
  • Blood products and preparations.
What are the Legislations which describe certification Procedure?
Directives 2001/82/EC and 2001/83/EC, as amended, of the European Council and of the Parliament.
Guidelines to be referred for preparing Dossier to obtain a CEP 

Content of the Dossier for Chemical Purity and Microbiological Quality (PA/PH/CEP 04 1 4R)

Note: Click on the hyperlinks in blue for application form and template of QOS to download them.
Online Database of Approved CEPs
Link to Online Databases of Approved CEPs
Registration Fees 
Registration fees for various New CEP Applications  Deficiencies
 Link to top 10 deficiencies in New Applications for grant of CEPs Recognition of CEPs- CEPs are recognised by all the member countries of the European Union and also   other Countries like Canada, Australia, New Zealand, Tunisia and Morocco.
 
Advantages of CEPs-
  •  It is valid for 5 Years.
  • An API manufacturer need not file an ASMF/EDMF in all the member countries involved in DCP/MRP Procedures if the manufacturer has obtained CEP for that specific API. Sending a Copy of CEP will do.
  • Centralised evaluation of Dossier by only one agency i.e EDQM.

References-

CERTIFICATE OF SUITABILITY 
 click for files

LEGAL

RESOLUTION AP-CSP (07) 1 TERMS OF REFERENCE
Registration Fees Products & Services Catalogue 2011 (English/French)

NEW SUBMISSION AND GUIDELINES

NEW SUBMISSION – APPLICATION FORM QUALITY OVERALL SUMMARY TEMPLATE

Guidelines

Content of the Dossier for Chemical Purity and Microbiological Quality (PA/PH/CEP 04 1 4R) Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2)
Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation Certificates of Suitability for Sterile Active Substances (PA/PH/Exp. CEP/T (06) 13, 1R)
Clarification on the Acceptability of CEP Applications for Sterile Grade Material (PA/PH/CEP (08) 60, November 2008) Explanatory note: Updated EDQM procedures related to Paper and Electronic Submissions for CEP applications (PA/PH/CEP (09) 109, 1R
Guidance for Submission of Electronic Documentation for Applications for Certificates of Suitability (CEPs): Revised Procedures (PA/PH/CEP (09) 108 Top Deficiencies Found During First Assessment of New Applications From October to December 2009, PA/PH/CEP (10) 65
New Procedure for the Assessment of Sister Files, PA/PH/CEP (09) 141 Note for the Applicants: Procedure for Validation of New Applications, PA/PH/Exp. CEP/T (08) 37
The EDQM‘s Position on CEPApplications for Biological Substances

REVISON AND RENEWALS GUIDELINES

REVISION APPLICATION FORM RENEWALS APPLICATION FORM
Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs, PA/PH/CEP (04) 2 4R  Explanatory Note: Updated EDQM Procedures related to Paper and Electronic Submissions for CEP Applications PA/PH/CEP (09) 109, 1R
Guidance for Submission of Electronic Documentation for Applications for Certificates of Suitability (CEPs): Revised Procedures PA/PH/CEP (09) 108, 1R Procedures for Management of Revisions/Renewals of Certificates of Suitability to the European Pharmacopoeia Monograph, PA/PH/Exp CEP/T (04) 18 2R

NEWS

Note concerning the assessment of stability data within the Certification procedure Packaging information within the Certification procedure
Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk GPS/DUNS information to be mentioned in the application forms
Refusal of information from third parties in reply to EDQM‘s request for information Update of monographs regarding limit for unspecified impurities            – List of monographs
Changes to Submitted Documentation No Longer Accepted During the Assessment Phase Change in Contact Details: Notify the EDQM
EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability’ PA/PH/CEP (08) 17, R2 The report on the international APIinspection pilot programme

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