The 19th round of the Professional Testing Scheme (PTS) of Medicines Quality Control Laboratories, organized by the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines with the support of the State Service of Ukraine on Medicines and Drugs Control, will be held from April 19, 2024.
Participation in external independent testing programs, such as the PTS, is not only a mandatory element of the quality assurance system of analytical laboratories following ISO and GMP/GLP requirements but also a valuable opportunity to enhance your laboratory's credibility. Since 2001, eighteen successful PTS rounds have been conducted, involving interested pharmaceutical laboratories.
The 19th PTS round continues the topic of uncertainty control of the functioning of the analytical system as a whole and assessment of the analyst's work when performing standard analysis operations.
The 19th PTS round presents participants with the following tasks, designed to test and enhance their analytical skills:
1) Work of an analyst with a volumetric flask.
The participant in the round is provided with a 100.0 ml test measuring flask containing a volume with a certified value. The precision of the dilution and the deviation of the contained volume from the certified value are evaluated.
The participating laboratory can involve up to five analysts in this test (paid as per one participant).
2) Quantitative determination of an analyte in solution by liquid chromatography.
The participant is provided with two test solutions of metronidazole, which simulate the drug, and a procedure of quantitative determination by liquid chromatography (the Ph.Eur. 2.2.29). The decision of the laboratory regarding the compliance of the metronidazole content with the given specification is evaluated (±5% of the nominal value).
The content of metronidazole in the test solutions is such that, provided the laboratory works within the requirements of the State Pharmacopoeia of Ukraine – SPhU (requirements of normal analytical practice for the uncertainty of sample preparation and requirements for the suitability of the chromatographic system), the laboratory with a probability of 99% must make a correct conclusion regarding the compliance of the analyte content with the specification.
Test samples for the task "Quantitative determination of an analyte in solution by liquid chromatography" are provided in the amount for one test. An additional set of samples for testing more than one analyst can be purchased by the laboratory for an additional fee.
Acceptability criteria of test results are established based on SPhU recommendations to the target uncertainty of quantitative tests (target uncertainty, Utg) and/or target uncertainties of standard sample preparation operations (normal analytical practice requirements).
Information about each participant's test results is confidential. Participants receive a certificate of participation in the PTS round and report on the results of the test, which provides a review of the obtained test results, investigates the causes of problems, and provides recommendations for their elimination.
At the end of the round, a scientific and methodical seminar will be held, which will consider the problems identified during the testing, summarize the experience gained, and provide recommendations.
To participate in the 19th round of PT, it is necessary to fill out the Application form and send it to the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines at the email: svetl.chikalova@gmail.com
Test samples/flasks will be mailed upon receipt of the application and payment of the organizational fee.
The test results should be provided to the organizers in electronic form (in PDF) at the email: svetl.chikalova@gmail.com. Please keep the original protocols in the laboratory.
To fill out the protocol based on the results of the test task, you should use the form in Word format. The form in PDF format is provided on the website so that you can check the correctness of its display in Word format.
Test Task No 1 and Form for results_Word format
Test Task No 1 and Form for results_pdf format
Test Task No 2 and Form for results_Word format
Test Task No 2 and Form for results_pdf format
Responsible for conducting the 19th round of PTS:
Dmytro LEONTIEV
Deputy director for science
head of the department of validation and reference standards
Tel. +38(050) 402 17 51
leontievd@yahoo.com
Responsible for PTS technical support:
Svitlana Chikalova,
senior researcher of the Department of Validation and Reference Samples
Tel. +38(093) 815 18 56