These activities involve the General European OMCL Network only.
Background
The quality management (QM) programme within the General European OMCL Network started in 1997 with a two-year pilot phase. A common approach for developing and implementing Quality Management systems (QMS) in all OMCLs of the Network had been agreed upon. This was especially important due to the increasing exchange of results and data (e.g. batch release of biologicals, market surveillance of centrally authorised products) among members. Since 1999, work in this area has intensified. It was decided to adopt a specific assistance and maintenance programme for QMS and to harmonise the quality management policies of the OMCLs. It was further agreed to refer to the ISO/IEC 17025 quality standard.
Activities
- Mutual Joint Visits (MJVs)
They are organised by the EDQM. These aim to advise and help OMCLs implement and/or improve their quality management systems.
- Mutual Joint Audits (MJAs)
MJAs of OMCLs are carried out by experts, from the Network, trained in Quality Management. These check that OMCLs quality management systems comply with the requirements laid down in ISO/IEC 17025, in the General European OMCL Network Quality Management Guidelines and in the European Pharmacopoeia. They take place on a routine basis.
- Education Activities
Education activities such as training visits and training courses educate OMCL staff in QM and/or on technical topics related to the implementation and improvement of OMCLs quality management systems.
- Quality Management Guidelines
They have been drafted by experts from the Network. They aim to support laboratories in implementing the ISO/IEC 17025 requirements, while taking into account the specific OMCL environment. From a legal point of view a guideline is not binding, but deviations from its content require a sound (and, if applicable, scientific based) justification.
- Recommendation Documents
They have been drafted by experts from the OMCL Network. Similar to the QM-Guidelines they shall support laboratories in implementing the ISO/IEC 17025 requirements. They provide guidance for OMCLs of the GEON or a specific network without binding character.
Following meetings with representatives of the European co-operation for accreditation (EA) and presentations given at meetings of the EA Laboratory Committee, the EDQM has been accepted as “Recognised Stakeholder” of the EA in 2013. This recognition will foster future co-operation, exchange of information and mutual acceptance of audit results. The EA now officially supports the performance of joint audits between National Accreditation bodies and EDQM/OMCL experts. The EA confirmed the use of the EDQM’s quality management guidelines in QMS audits of OMCLs by accreditation bodies.
In 2017 an EA-EDQM joint document has been published on the EA website: EA-INF/15:2017 Joint EA - EDQM Communication regarding cooperation when carrying out (joint) audits/assessments in Official Medicines Control Laboratories.
For a list of these guidelines, click HERE.
Also the members of the OMCL Network officially support the idea of joint audits and express this position in the paper “Complementary Mutual Joint Audits in OMCLs accredited against ISO/IEC 17025”.
Achievements in 2023
Quality Management Programme
In 2023, the EDQM successfully continued to co-ordinate the activities and implement the work programmes – including the Quality Management (QM) programme – of the General European Network of OMCLs (GEON).
The primary aims of the GEON QM programme remain harmonising quality management systems (QMS) across the Network and achieving appropriate quality levels that make mutual recognition of test results between members possible for a variety of testing schemes, including official batch release testing of biologicals, market surveillance of authorised medicines and falsified medicines testing.
Mutual Joint Audits/Visits and Training Visits
The Network has a system of Mutual Joint Audits and Visits (MJAs/MJVs) in place to assess the compliance of OMCLs with the quality requirements laid down in ISO/IEC 17025, the Network’s QM guidelines and the European Pharmacopoeia.
In 2023 the MJAs were performed on-site with some hybrid elements whenever necessary Sixteen MJAs (including fifteen full and one surveillance MJA) took place in 2023. This brings the total since the launch of the OMCL QM programme in 1997 to 239 MJAs, 52 MJVs and 27 Training Visits/tutorials.
OMCL Network Quality Management Documents
Two Guidelines, nine General Annexes, one procedure and Explanatory Notes document were adopted/published in 2023:
- Qualification of Equipment - Core Document
- Qualification of Equipment Annex 1: Qualification of Liquid Chromatography Equipment
- Qualification of Equipment Annex 7: Qualification of Mass Spectrometer
- Qualification of Equipment Annex 8: Qualification of Balances
- Evaluation and Reporting of Results – Core Document
- ANNEX 1 to Guideline Evaluation and Reporting of Results – Rounding
- ANNEX 2 to Guideline Evaluation and Reporting of Results – Evaluation of results from quantitative testing
- ANNEX 3.1 to Guideline Evaluation and Reporting of Results – General introduction – Verification of initial out-of-specification (OOS) results
- ANNEX 3.2 to Guideline Evaluation and Reporting of Results – Verification of OOS results in quantitative testing
- ANNEX 3.3 to Guideline Evaluation and Reporting of Results – Verification of OOS results in qualitative testing
- ANNEX 3.4 to Guideline Evaluation and Reporting of Results – Special Considerations from Animal Testing in connection with verification of OOS Results
- Management of OMCL Network Documents and Records by the EDQM
- Preface and Notes for Use of OMCL Quality Management Documents
The EDQM’s co-ordination activities with respect to the QM programme are ISO 9001 certified by AFNOR and audited on a regular basis.
