CEP 2.0 - changes at a glance

CEP

CEP 2.0

Information reported on the CEP

Numbering system – includes renewal indicator.

Numbering system – renewal indicator removed.

Name and address of holder and production sites

Name and address of holder and production sites as well as ORG ID and LOC ID from EMA SPOR/OMS database are included

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To foster more awareness that CEP holders have responsibilities towards their customer, a legal commitment for CEP holders to share information with their customers to guarantee quality, safety, and efficacy is included in the CEP. This aspect will now be checked during GMP inspections.

Legal statement regarding the granting of the CEP within the framework of the procedure established by the European Pharmacopeia Commission is included

Legal statement regarding the granting of the CEP within the framework of the procedure established by the European Pharmacopeia Commission has been revised

Declaration of access box on the CEP document

Declaration of access box on the CEP document has been replaced by a separate letter of access for which a template is available on the EDQM website here.

Additional control specifications e.g., impurities/residual solvents reported on the CEP

Additional control specifications have been replaced with the full specification in tabular format with acceptance criteria and methods detailed which is appended to the CEP as Annex 2

If water is used in the last steps of synthesis it is reported on the CEP that water is used, however, the specific quality of water (e.g., purified water, deionised water, water for injection) is not listed unless it is water for injection for sterile APIs

Specific quality of water will now always be listed on the CEP if water is used in the last steps of synthesis.

Expiry date included

Expiry date not mentioned on the CEP – renewal due date is listed on the EDQM public certification database. Access the database here

Hard copy CEP with wet signature

Electronic CEP with digital signature

For details on electronic signature features please refer to EDQM guidance here

Dossier Content and Assessment of CEP Applications

Requirements according to CEP

Key areas to review in accordance with CEP 2.0.

• Claimed CEP substance grade and harmonisation of reference throughout the dossier
• Maximum daily dose
• Specific quality of water used in the manufacturing process must be defined.
• Specification requirements
• Analytical methods (Ph.Eur vs in-house alternative methods and additional methods)
• Stability policy (process for retest period claims versus no retest and storage conditions)

For detailed guidance on how the dossier content should be presented and the level of detail to be included going forward please refer to ‘'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’ as issued by the EDQM

Revision Procedure

Revised CEP issued after any notification/minor revisions impacting the content of the CEP, after any major revisions even if the content of the CEP was not impacted and after each renewal

A new CEP version will only be issued when a minor/major change is introduced that impacts the CEP document content - there will no longer be a CEP revision by default for major changes or renewals

EDQM Certification Database

Details according to the below screenshot

Additional columns added to represent the following information.

• SPOR ORG-ID and LOC-ID for the CEP Holder
• Renewal due date for the CEP
• Closure date of last procedure

In addition, the CEP number within the Certification Database table now links to a line listing of CEP procedures opened from 1 January 2020 along with their outcome and closure date

Authorities Database

The database is currently accessible by the licensing authorities of the member states of the Ph. Eur. Convention

Regulatory Authorities outside of the Ph. Eur that accept CEPs have now been given access to the EDQM Authorities Database under confidentiality agreements or Memoranda of Understanding

A list of authorities and organizations who may have access to assessment and/or inspection reports is available here.