EDQM updates two Guidelines on the CEP procedure

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The set of "Certification Policy Documents & Guidelines" regarding the CEP procedure contained two guidelines that no longer corresponded to the current practice. Therefore, the EDQM has revised them. In July this year, the updated versions of these guidelines were published on the EDQM website:

• Terms of Reference (PA/PH/CEP (01) 1, 11 R Cor)
• Code of Practice for the Certification procedure (PA/PH/CEP (02) 04 3R)

The most important changes to the two documents are summarized below.

Terms of Reference (PA/PH/CEP (01) 1, 11 R Cor)

This document describes the requirements to be met by the bodies and persons involved in the CEP procedure.
The revised version of the document contains the following updates:

Steering Committee (SC):

• Where possible, SC decisions should be taken by consensus. In the absence of consensus, the decision is taken by a simple majority (half of the SC members plus 1).
• The SC makes proposals for updating guidelines and pharmacopoeia monographs. In this context, the SC is responsible for taking into account not only the needs of CEP applicants, the Pharmacopoeia Commission and the regulatory authorities, but also those of the European supervisory authorities.
• All documents sent on behalf of the SC shall be signed by the chair of the SC.

Assessors:

• Assessors are formally proposed by the relevant authorities. The three-year period of office of the assessors is renewable every three years for an unlimited number of terms.
• Scientific staff of the certification department are formally proposed by the EDQM and appointed by the SC for an unlimited period of time, as long as they belong to the certification department and fulfil the criteria for the assessor's activity.

Inspectors:

• Inspectors are nominated by their competent authorities for a period of three years, which is renewable every three years for an unlimited number of terms.
• The inspectors take part in the annual EDQM inspection programme adopted by the SC. They are responsible, among other things, for registering the planned inspections in the EUDRA GMDP planning module.

Technical Advisory Board (TAB):

• In the TABs for the various scientific/technical fields there is also a member of the certification department of the EDQM, preferably an assessor. The members of a TAB are appointed by the SC for a three-year period, renewable only once. The same applies to the three-year period of the chair elected by the SC.
• Decisions of the TABs should be taken by consensus. In the absence of consensus, a simple majority (half of the TAB members attending a meeting plus 1) is sufficient.

Internal Decision Board (IDB):

• The IDB ensures that the inspections conducted in the frame of the certification procedure are carried out in accordance with the established specifications and that the inspection outcomes are harmonized according to the standards.
• Besides, the IDB also ensures that the CEP holders maintain their applications according to established procedure.

Ad Hoc Committee:

• The members of the Ad Hoc Committee are taken from the group of assessors and inspectors who participate in the CEP procedure. If necessary, the Certification Department issues a call for candidates for the Ad Hoc Committee; they have a three-year membership which is renewable.

The Certification Department (DCEP):

The DCEP is responsible for the issuance of attestations of inspections, information on measures relating to CEPs or CEP applications and for granting CEPs. It also liaises with other regulatory authorities and with the relevant Working Parties and Working Groups of the EMA.

Altogether, the changes in the updated Guideline concern not only the exact deadline regulation for the various functionaries, but above all the extension of responsibilities and competencies of the bodies involved in the certification procedure.

Code of Practice for the Certification procedure (PA/PH/CEP (02) 04 3R)

This document contains rules of conduct for all persons involved in the certification process.
The revised version of this document contains the following changes:

• The assessors for the evaluation of CEP applications are appointed by the SC of the Certification Department. The profile criteria of these persons are:
  - Scientists with experience in the assessment of marketing authorisation or CEP applications, either from or advising the competent authorities,
  - Staff of the EDQM Certification Department with experience in the assessment of CEP applications.
  Employees from official Medical Control Laboratories (OMCLs) are no longer mentioned in the updated document.
• Stricter rules apply to assessors and inspectors in relation to conflicts of interest. Their activities are restricted for companies associated with the conflict of interest.
• The evaluation of a CEP application and the performance of an inspection are carried out by a team of two assessors and two inspectors respectively. A consensus shall be reached on the outcome. All activities of the assessors and inspectors are subjected to a peer review by the Certification Department.

In general, the changes serve to clearly regulate and ensure the independence of assessors and inspectors and to avoid conflicts of interest.