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Proficiency Testing Studies (PTS)
An European programme open to OMCLs and other medicine control Laboratories
Aims of the Scheme
To ensure that the results obtained by the various Official Medicines Control Laboratories (OMCLs) in the Network are comparable and that the participants maintain their performance, PTS are regularly carried out on basic methods of analysis. Proficiency testing is a form of external quality control using interlaboratory comparisons to determine the performance of individual laboratories for specific tests or measurements and to monitor laboratories’ continuing performance. Participating in proficiency testing provides laboratories with an objective means of assessing and demonstrating the reliability of the data they are producing. It supplements laboratories’ own internal quality control procedures by providing an additional external measure of their testing capability.
The programme was extended in 2000 to pharmaceutical technology methods (such as dissolution testing, disintegration, etc.) and to other pharmaceutical laboratories not belonging to the OMCL Network.
About 5-6 studies per year are organised in the physico-chemical area with an average participation of 50 laboratories (OMCLs and non-OMCLs). In the area of biologicals, about 4 studies per year are offered. PTS studies help build mutual trust between OMCLs. They constitute an important component of an effective common system for quality assurance and performance measuring.
Who organises the testing and who can participate?
The EDQM organises, co-ordinates and manages the scheme. Laboratories can participate in the programme following registration. Participation is free for OMCLs but subject to payment for laboratories not belonging to the Network (see products and services)
Achievements in 2008
In 2008, 5 studies were organised in the physico-chemical field, with an average participation of 37 national control laboratories and 27 other pharmaceutical control laboratories, private sector industry and hospitals, while in the biological area 4 studies were organised, involving an average of 11 OMCLs and 10 laboratories from the private sector.
Concerning the 4th PTS agreement with WHO, 4 out of 5 studies included in the programme were finalised and the 5th one was initiated. On average 50 governmental control laboratories belonging to 6 different world regions (Africa, Americas, Eastern Mediterranean, Europe, South-East Asia and Western Pacific) participate in these studies.
PTS Biological Registration Form 2009
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
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