A European Scheme Open to the General European OMCLs Network and other Medicines Control Laboratories
Background
The Proficiency Testing Scheme (PTS) is a form of external assessment of quality control management systems using inter-laboratory comparisons to determine the performance of individual laboratories in carrying out specific tests or measurements. This supplements laboratories' internal quality control procedures by providing an external measure of their testing capability.
The EDQM designs and organises the Proficiency Testing Scheme following the principles of "ISO/IEC 17043 Conformity Assessment - General Requirements for proficiency testing". Primarily, the scheme aims to ensure that the results obtained within the General European OMCL Network are comparable and that members maintain their performance. With this in mind, PTS studies are regularly carried out on basic methods of analysis in the biological and physico-chemical fields (including on methods used in pharmaceutical technology such as dissolution testing) in the framework of ISO/IEC 17025-the standard chosen by the General European OMCL Network.
Participation in the scheme provides laboratories with an objective means for assessing and demonstrating the reliability of their data. This helps build mutual trust between OMCLs - an important component of an effective common system for the quality control of medicines.
A number of studies are organised each year in the physico-chemical area and in the area of biologicals.
Who Organises the Scheme and Who Can Participate?
The EDQM organises, co-ordinates and manages the scheme. Following registration, any control laboratory can participate. Participation is free for members of the General European OMCL Network but subject to payment for non-members.
Achievements in 2022
In 2022, 4 studies were proposed in the physico-chemical area: PTS225 on Optical rotation, PTS226 on Liquid chromatography, PTS227 on Determination of N-nitroso-dimethylamine (NDMA) in valsartan tablets and PTS228 on Refractive index. PTS229 on Osmolality has been postponed to the first quarter of 2023. An average of 82 laboratories (OMCLs and other medicines control laboratories, for example, from the pharmaceutical industry, from hospital pharmacies, universities and pharmacy associations) participated in these studies.
In the biological area, 5 studies were organised: PTS230 on Hepatitis C virus testing of plasma pools by nucleic acid amplification techniques (NAT), PTS231 on Parvovirus B19 DNA testing of plasma pools by NAT, PTS232 on Hepatitis A virus testing of plasma pools by NAT, PTS233 on Bacterial endotoxins (for blood products) and PTS234 on the molecular-size distribution test in albumin. These studies involved on average 24 laboratories (OMCLs and others).
The EDQM’s coordination activities with respect to the PTS physico-chemical and biological Programmes are ISO 9001 certified by AFNOR Certification and audited on a regular basis. The last audit took place in February 2022 and the next one is scheduled for February 2023.
