Image created by Dr. Michael J. Miller
At its 184th Session in March 2026, the European Pharmacopoeia Commission (EPC) approved the creation of a new working party dedicated to the technical development of the certified review of microbiological methods per the European Pharmacopoeia, a novel concept that will also be known as “cMEP”.
The cMEP is based on a method‑centric approach intended to facilitate the use of rapid microbiological methods (RMMs) by providing a harmonised scientific review of their validation and comparability, in accordance with the European Pharmacopoeia.
Developed under the aegis of the EPC, the cMEP arose from recent EDQM work on the implementation and assessment of RMMs. This work included two major stakeholder consultations (April and October 2024), which confirmed strong and broad support for the development of such a certification approach.
The newly created cMEP Working Party will contribute to the technical development of the concept, including the refinement of its scope and scientific requirements.
The Terms of Reference for the Working Party are as follows:
cMEP Working Party (certified review of microbiological methods per the European Pharmacopoeia)
Terms of reference
- Support the refinement of the scheme, including:
- Paper exercise based on the feedback gathered during the opportunity study and the early technical taskforce
- Refinement of the scope and drafting of the certified review concept for alternative microbiological methods, covering validation and comparability to Ph. Eur. reference methods (and excluding product-specific validation and comparability)
- Draft proposal of the technical and operational framework, including guidance for applicants, templates of data package needed for the review, and the system way-of-working
- Execute a proof‑of‑concept exercise (preferably on a well-known alternative analytical method and an equipment already used for an approved product) in order to test the proposed concept, identify scientific and practical bottlenecks and propose remedies ahead of a pilot phase.
- Consultation with relevant Ph. Eur. groups (e.g. Group 1, CTP, GTP) and with stakeholders (e.g. via targeted hearings/workshops) when required
Profile for experts
- Current expertise in microbiological analytical methods and/or analytical validation relevant to the development, implementation or assessment of alternative microbiological methods
- Several years of recent experience in one or more of the following fields:
- Development, implementation (incl. validation and comparability) of alternative microbiological methods in industry or contract laboratories (method implementation, change control, batch release, troubleshooting)
- Practical microbiological QC experience in manufacturing or independent testing laboratories (diverse matrices, large organism panels)
- Assessment of validation and comparability packages for relevant quality dossiers and familiarity with rapid methods, sterility, bioburden, in a competent authority or OMCL
- Consultancy with substantial experience in the implementation or filing of alternative 46 microbiological methods
- Development and maintenance of alternative microbiological equipment (principle, hardware, software/algorithms, versioning, primary validation, comparability, data collection, awareness of method limitations and challenges, understanding of user needs)
- Knowledge of Ph. Eur. chapter 5.1.6 (and/or 2.6.27) as well as other relevant texts (incl. 2.6.1, 2.6.12, 2.6.13, 2.6.7, 2.6.21)
- Ability to contribute constructively to the project, including participation in consensus drafting and review of working documents
Profile for ad hoc specialists
- Statistician specialised in microbiological validation and comparability
- ATMP / short shelf-life product specialist with knowledge of rapid sterility and time-critical constraints, low-volume sampling, and matrix effects specific to cell-based/short-shelf-life products, experience with tests with long analytical time (e.g. sterility, mycoplasma) and their alternatives methods
- Regulator experienced in the assessment of the alternative microbiological methods parts of applications for marketing authorisation in a competent authority or OMCL
- Technology/method specialist (e.g. equipment supplier) with full knowledge of method principle/hardware/software, method limitations and challenges