The mission of the procedure for the ‘Certification of suitability to the monographs of the European Pharmacopoeia' is to:
- assess and conclude suitability of monographs to control the chemical purity, microbiological quality and TSE risk (if relevant) for any substance covered by a European Pharmacopoeia monograph,
- check compliance at the manufacturing and/or distribution site(s) covered by Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) with both Good Manufacturing Practice (GMP) for medicinal products for human or veterinary use and with the CEP granted according to the information submitted in the application(s) for CEP(s).
Based on a centralised assessment of applications describing the manufacture and quality control of substances for pharmaceutical use, the procedure:
- facilitates and simplifies exchanges between regulators and industry to ensure that the quality of substances used in the production of pharmaceutical products is guaranteed and that these substances comply with the European Pharmacopoeia and therefore with the requirements of the relevant EU legislation
- facilitates the management of marketing authorisation applications for medicinal products
- acts as a complement to and a bridge between European Pharmacopoeia monographs and the need to submit a marketing authorisation dossier for a medicinal product
- acts as a bridge between health authorities and industry
- optimises the use of scarce resources available to public health authorities
- optimises the use of scarce resources available for the inspection through close collaboration with European and non-European authorities.
The Steering Committee implements the 3Cs (consultation, co-ordination and co-operation) that characterise the certification procedure. Its members are representatives of public health authorities. Its primary responsibilities are to:
- take decisions on general policy
- review and comment on issues raised by the Technical Advisory Boards
- adopt guidelines and the inspection programme
- co-ordinate issues between the parties represented before it
- appoint the assessors and the Technical Advisory Boards (TABs) and their respective Chairs.
The Technical Advisory Boards (TABs) have been set up for each field of the procedure (chemical substances and products with a risk of transmissible spongiform encephalopathy (TSE)). These Boards consist of assessors nominated by national competent authorities to participate in the CEP procedure. They deal with technical or scientific questions raised by the assessors, discuss technical guidance documents, submit scientific or technical issues to the Steering Committee and seek its advice whenever necessary.
The Assessors are scientists with professional experience in assessment of marketing authorisation or CEP applications, belonging to or advising national competent authorities responsible for the evaluation of marketing authorisation applications or to Official Medicines Control Laboratories (OMCL), or scientific administrators belonging to the EDQM Certification Department (DCEP). They have appropriate qualifications for the evaluation of dossiers in one of the fields covered by the Certification Procedure. They perform the scientific assessment of applications submitted by manufacturers and draw up evaluation reports. All assessments take place on the EDQM's premises.
The Inspectors are officials appointed by the competent authorities in the EU/EEA, or in countries which have a Mutual Recognition Agreement with the EU in GMP sector, or EDQM inspectors belonging to the Certification Department having the same qualification.
The EDQM Certification Department is a team of scientific administrators, inspectors, secretaries and technicians responsible for managing, in a confidential manner, the applications and the inspections.
For more information, see the Terms of Reference.