Proficiency testing (PT) is among the key quality assurance tool that is used to determine the performance of laboratories for specific tests and therefore, is important in monitoring the laboratories’ continuing performance. Proficiency testing involves comparing test results obtained from different laboratories after testing the same sample. In a proficiency test scheme, PT provider distributes standardized samples to different participating laboratories for analysis. These laboratories test the sample using their routine methods of analysis, record the results and submit them to PT provider for evaluation.
Test results from different laboratories are compared to the reference values followed by preparation of the report which is sent to the participating laboratories. The report provides an opportunity for a laboratory to evaluate its performance among other laboratories. Z-score is used as a measure of satisfactory performance whereby values between -2 and 2 indicate satisfactory results; whereas any value beyond this range indicates unsatisfactory results.
Upon receipt of PT results, participating laboratories are required to conduct evaluation and carry out investigation in order to identify the root cause for the unsatisfactory test results. These investigations enable laboratories to take corrective action for further improvements.
TMDA Quality Control Laboratory participates in various PT Schemes as part of the requirement of laboratory quality management systems. This enables TMDA laboratory to assess its competence in laboratory analysis and allows monitoring of trends in quality of its measurements over time.
TMDA Quality Control Laboratory utilizes an annual schedule for participation in PT schemes. In addition, evaluation of all PT results received is carried out at the end of every three (3) years, for the purpose of assessing trends and taking necessary measures.
The laboratory participates in PT schemes from the following providers:
- World Health Organization (WHO)
- European Directorate for the Quality of Medicines & HealthCare (EDQM)
- African Medicines Quality Forum (AMQF)
- Physikalisch Technische Bundesanstalt (PTB)
- School of Pharmacy R & D lab - MUHAS
Participation in Proficiency Testing Scheme is a requirement of laboratory quality management systems that are implemented at TMDA laboratory, this includes: