During the week of 4 – 8 February 2019, an additional mission on the Developing New Tasks for the Quality Control Laboratory within the Activity 5.3 of the EU funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” has been conducted.
During the visit, Short Term Experts from the States Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, Ms. Roma Mockutė and Ms. Vestina Urbanavičienė together with the Resident Twining Adviser Ms. Anželika Oraitė, visited the Quality Control Laboratory of the MMDA.
Ms. Roma Mockutė and Ms. Vestina Urbanavičienė drew attention to the changes in International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories, agreed interpretations and provided suggestions on how to implement the new requirements in line with the mandate and activities of the Quality Control Laboratory of the MMDA,
presented topics on the changes, reviewed the current Quality Control Laboratory of the MMDA policy for impartiality in relation to quality documents, conducted review on the Quality Control Laboratory of the MMDA sampling system, ensuring the validity of test results in relation to management of documents, as well as the current Quality Control Laboratory of the MMDA policy for confidentiality in relation to national legislation. Short Term Expert drew attention to the current management structure of Quality Control Laboratory of the MMDA and provided suggestions on how to implement the new structural requirement in relation to International Standard ISO/IEC 17025:2017.
In addition, two-day training on Evaluation of Measurement Uncertainty: ISO/IEC 17025:2017 has been conducted by Ms. Roma Mockutė and Ms. Vestina Urbanavičienė. In total, 14 experts from the Quality Control Laboratory of the MMDA attended the event. As a result, more than 90 % of attendees evaluated training as excellent emphasizing the usefulness of the topics presented as well as high competence of the trainers.