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Physico-chemical and Biological PTS

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 according to "ISO/IEC 17043:2010 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 2019

In 2019, 5 studies were organised in the physico-chemical area: PTS193 on Determination of water by coulometry, PTS194 on Optical rotation, PTS195 on Infrared absorption spectrophotometry, PTS196 on Dissolution and PTS197 on Liquid Chromatography. An average of 98 laboratories (OMCLs and other medicines control laboratories, for example, from the pharmaceutical industry, from hospital pharmacies, universities and pharmacy associations) participated. 

In the biological area, 6 studies were organised: PTS198 on Hepatitis E virus testing of plasma pools by nucleic acid amplification techniques (NAT), PTS199 on Hepatitis A virus testing of plasma pools by NAT, PTS200 on Hepatitis C virus testing of plasma pools by NAT, PTS201 on Immunoglobulin protein composition, PTS202 on Immunoglobulin molecular-size distribution and PTS203 on Bacterial endotoxins (vaccine samples), whose experimental phase is foreseen for Q1 2020. These studies involved on average 21 laboratories.

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