Testing laboratories are invited to participate in the PLV, in particular:
• quality control laboratories for medicinal products,
• medical devices,
• cosmetics,
• food products,
• dietary supplements, etc.,
which use analytical equipment for quantitative chemical analysis in their activities, in particular:
• scales (for weighing procedures),
• high-performance liquid chromatography (for quantitative determination of components) .
Start of the PLV round: August 2025
The PLV program provider is the State Institution "O.M. Marzeev Institute of Public Health of the National Academy of Medical Sciences of Ukraine". The provider operates in accordance with the requirements of DSTU EN ISO/IEC 17043:2017 "Conformity assessment. General requirements for professional level verification".
Regular independent assessment of the laboratory's technical competence is a necessary component of the quality assurance system and the guarantee of the reliability of the results.
According to DSTU ISO/IEC 17025:2019, the participation of laboratories in the PLV programs is mandatory.
For pharmaceutical quality control laboratories, participation in the PLV is an important element of quality assurance.
Given the interest of laboratories in implementing the concept of measurement uncertainty, the following tasks are proposed to laboratories:
Task 1. Verification of the uncertainty of the weighing procedure.
In most analytical laboratories, the weighing of samples is carried out in weighing containers. The container may have a mass that is:
• comparable to the sample (optimal case), or
• significantly larger (e.g. weighing in a volumetric flask).
The uncertainty of the entire weighing operation increases with increasing container mass. However, current procedures for estimating the uncertainty of a weighing operation do not take into account the influence of container mass, which results in:
• incorrect uncertainty assessment,
• insufficient control over risks linked to potentially unacceptably high uncertainty in weighing.
Moreover, assessing weighing operations is quite challenging (2, Example A), as analysts often need to independently combine the uncertainty components for the weighing process, necessitating the expertise of an experienced metrologist. Due to the absence of an uncertainty assessment procedure tailored to laboratory practice, there is a risk of employing a formal approach to evaluating the risks of weighing operations, which fails to ensure quality control of the analysis process and merely squanders laboratory resources.
IMPORTANT: Ph.Eur. (2.1.7. BALANCES FOR ANALYTICAL PURPOSES) specifies that it is the laboratory's duty to assess the influence of the container on the quality of the analytical results, particularly when there is a risk of deterioration.
We provide a streamlined and effective uncertainty assessment procedure that:
• oriented towards the actual conditions of laboratory weighingp practice,
• can be effectively incorporated into the overall process of assessing uncertainty in the analytical results conducted by the laboratory.
As part of the assignment, laboratories receive:
• simulators of "containers" and "weights", which must be returned to the Provider following testing,
• protocol with instructions for performing measurements that replicate a weighing operation.
Participants are encouraged to perform a weighing uncertainty assessment in accordance with accepted laboratory practices.
The Provider evaluates participants using the z-criterion, and drug quality control laboratories - additionally using pharmacopoeial recommendations.
Based on the results obtained, the Provider will:
• determines the verified uncertainty value for weighing a specified mass (minimum weight, maximum container mass),
• provides a report on the PLV round along with an analysis of the results.
Participants receive an adapted procedure for verifying the uncertainty of a weighing operation, which can also be utilized to monitor the uncertainty of weighing and to verify the uncertainty of other (smaller or larger) combinations of weights and weighing containers.
IMPORTANT: The proposed procedure for verifying the uncertainty of the weighing operation considers the recommendations of DSTU ISO/IEC 17025:2019 regarding uncertainty assessment, and in the context of quality control for medicines, aligns with pharmacopoeial standardization.
Participation fee: 7,300 UAH, excluding value-added tax (VAT).
Task 2. Verification of uncertainty for the quantitative determination test by liquid chromatography.
According to pharmacopoeial practices, a method that is reproduced for the first time in a laboratory is subject to verification or transfer, meaning experimental confirmation that all significant factors of variation are controlled in the receiving laboratory.
According to DSTU ISO/IEC 17025:2019 (clause 7.6.3, Note 2), the laboratory does not need to estimate uncertainty for every single analysis if the uncertainty has already been estimated and verified, and the laboratory can confirm that critical factors of variation are under control.
This method aligns with pharmacopoeial practice.
High-performance liquid chromatography (HPLC) is the most widely used method for performing quantitative tests, the results of which necessitate uncertainty assessment in line with the requirements of DSTU ISO/IEC 17025:2019.
We invite laboratories to engage in testing to evaluate the accuracy of reproducing a standard quantitative determination method in substances or dosage forms using HPLC.
As part of the assignment, laboratories receive:
• test samples (TS),
• protocol outlining the uncertainty verification procedure for the analysis method.
Participants are invited to perform a measurement uncertainty assessment in accordance with accepted laboratory practices.
The Provider assesses participants based on the z-index (this information can be utilized by laboratories in accordance with their internal quality systems), while drug quality control laboratories evaluate based on pharmacopeial recommendations.
Based on the results obtained, the Provider will:
• draws a conclusion regarding the success of replicating the method,
• provides a report on the PLV round along with an analysis of the results.
Participants receive a measurement uncertainty verification procedure that can be further adapted for the verification or transfer of similar techniques.
The conclusion about the successful reproduction of the technique can be applied to similar techniques that depend on the same analytical operations.
IMPORTANT: the proposed procedure for verifying measurement uncertainty considers DSTU ISO/IEC 17025:2019 recommendations for uncertainty assessment, and in the context of quality control of medicines, aligns with pharmacopoeial standardization.
Participation Fee:
• 9900 UAH, excluding VAT - essential kit for 3 analysts.
• 2500 UAH, excluding VAT – additional package for one analyst.
Contact information:
State Institution "O.M. Marzeev Institute of Public Health of the National Academy of Medical Sciences of Ukraine" (State Research Laboratory for Quality Control of Medicines and Laboratory for Quality Control and Product Safety)
Address:
Kyiv, 50 Hetman Pavla Polubotka (Popudrenka) St.
Tel.: +380 (44) 513-71-33, +380 (44) 292-14-17
Fax: +380 (44) 292-14-21
E-mail: druglab@ukr.net
Responsible for the round:
Dmitry LEONTIEV
+38 (067) 954 91 74
leontievd@yahoo.com
Natalia OSTANINA
+38 (067) 528 79 52
Information about the PLV program Provider
Application for participation in the PLV (text in Ukrainian)
