Certification Policy Documents & Guidelines
Explore the EDQM’s Certification Policy Documents and Guidelines to access essential resources for the Certification of Suitability (CEP) procedure. This section provides up-to-date regulatory guidance, technical advice, and operational documents to support pharmaceutical ingredients manufacturers and stakeholders in preparing their CEP applications.
Governance documents
These documents describe the background and the legal framework of the Certification Procedure. They clarify its mission and organisation.
- Guide for declassification of documents pertaining to the CEP procedure (PA/PH/CEP (23) 29)
- CEP holders responsibilities towards their customers (PA/PH/CEP (21) 57)
- Resolution AP-CSP (07) 1 on the 'Certification of Suitability to the Monographs of the European Pharmacopoeia (Revised Version)'
- Rules of Procedure of the European Pharmacopoeia containing in Annex 1 the Terms of Reference of the Certification of suitability procedure PA/PH/Exp. ROP/T (24) 2
- Rules of Procedure CEP PA/PH/CEP (24) 42
- Code of Practice for the Certification Procedure (PA/PH/CEP (02) 04 4 R)
- Guideline 'How to read a CEP' (PA/PH/CEP (15) 31)
- Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure (PA/PH/CEP (13) 110, 3 R)
- Complaints procedure (PA/PH/CEP (15) 19 1R)
- Management of CEP guidelines and operational documents for the CEP procedure (PA/PH/CEP (22) 44)
- Refusal of information from third parties in reply to EDQM's request for information (PA/PH/CEP (11) 18)
- Technical Advice to Applicants and Holders of Certificates of Suitability (CEP), PA/PH/Exp. CEP/T (04) 27, 5R)
Operational documents
These documents are related to the practical aspects of the Certification procedure (management of documents, fees, maintenance of CEP, administrative information)
Information related to CEP document
- Letter of access template
- 'How to read a CEP' (PA/PH/CEP (15) 31, 1R)
- Electronic signature features (PA/PH/CEP (23) 50)
CEP application / CEP lifecycle
- User guide for Certification On-Line database (PA/PH/CEP (23) 56)
- Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure (PA/PH/CEP (13) 110, 3 R)
- Complaints procedure (PA/PH/CEP (15) 19 1R)
- Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2 7R corr)
How to build a good CEP application
These documents (including applications forms) are available for CEP holders and applicants to assist them in preparing a high-quality dossier and addressing guidance to be followed for specific technical points.
Content of a dossier
- Unique identification of manufacturing sites linked to CEP applications using SPOR OMS and GPS coordinates PA/PH/CEP (10) 118, 4R
- Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 7R
- Template for Quality Overall Summary to be submitted for Certification applications (PA/PH/CEP (15) 26 1R, January 2024)
- Content of the dossier for sterile substances, PA/PH/CEP (23) 54
- Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2 1R)
- Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation (PA/PH/CEP (02) 6 1R)
- Guidance on Applications for “Sister Files” (PA/PH/CEP (09) 141 2R)
- Top Ten Deficiencies in New Applications for Certificates of Suitability for Chemical Purity PA/PH/CEP (24) 10
- Use of a CEP to describe a material used in an application for another CEP (PA/PH/CEP (14) 06 1R)
- Implementation of policy on elemental impurities in the Certification Procedure PA/PH/CEP (16) 23, 2R
Specific guidance
- The use of carrier oils for antioxidants in Omega-3 Type Substances (PA/PH/CEP (16) 30)
- New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations according to the CEP 2.0 (PA/PH/CEP (23) 21 1R)
- API-Mix (or mixtures) and CEPs (PA/PH/CEP (16) 70
Application forms
- Application form “Request for new Certificate of Suitability”
- Application form request for sister file
- Application form "Request for Revision or renewal of Certificate of Suitability"
- Request for Technical Advice Meeting for Certificate of Suitability
Electronic submissions