Ensuring drug quality standards

Over the years, the Provincial Testing Center (under the Provincial Department of Health ) has intensified its efforts in inspecting, monitoring, and managing the quality of medicines and cosmetics produced, stored, circulated, and used locally.

To ensure high-quality testing of drug and cosmetic samples, the Provincial Testing Center maintains a quality management system according to ISO/IEC 17025:2017 standards and the principles and standards of "Good Laboratory Practice - GLP" with 33 test methods. Basic equipment, included in the list of equipment for drug testing laboratories (as recommended by the WHO in 2002), has been effectively used for analyzing and evaluating the quality of essential medicines circulating in the province. Several modern testing techniques have been increasingly applied, such as high-performance liquid chromatography (HPLC) and ultraviolet-visible (UV-VIS) absorption spectroscopy.

Currently, 100% of provincial and district hospitals, district and city health centers, and drug warehouses of pharmaceutical companies are subject to quality control and sample testing at least once a year. Each district, town, and city has at least one regional polyclinic and two commune health stations that are also subject to quality control and sample testing. In addition, this practice is also applied to over 50% of pharmacies and drug stores in the area.

Ms. Pham Bich Van, Deputy Director of the Department of Health and Director of the Provincial Testing Center, said: "We regularly organize inspections and monitoring of drug businesses and distributors in the province, with particular emphasis on inspecting drugs that are easily altered or degraded in quality, drug counters in remote areas, and commune health stations."

The inspection and monitoring of drug quality, including sample collection for testing, will be based on the list of active ingredients and priority medicinal herbs for quality testing. Sample collection will be conducted at the facilities. Drug quality inspection and evaluation will be carried out in accordance with quality requirements and standards to ensure that people have access to safe and high-quality drugs. In 2022, the Provincial Testing Center established 17 teams to collect drug samples for quality monitoring at 158 facilities, with a total of 822 samples collected, and one sample found to be substandard. In the first four months of 2023, the center established 6 teams to collect drug samples for quality monitoring at 50 pharmaceutical establishments in Lao Cai City and Van Ban District. Of the 262 samples collected, 260 were found to be of acceptable quality for use, and 60 samples are currently undergoing testing.

Pharmaceutical companies and private pharmacies in the province have enhanced their responsibility through self-inspection, quality control of medicines, and submission of samples for testing. However, currently, there are many new active ingredients and dosage forms that the testing center cannot yet test due to a lack of analytical equipment and reference standards. In addition, the quality standards of medicines from manufacturers have not been fully updated on the hethongkiemnghiem.vn software, therefore the Provincial Testing Center faces many difficulties in searching for and applying the correct quality standards.

Overcoming these difficulties, in the coming time, the Provincial Testing Center will research solutions to further improve the effectiveness of testing as well as the management of the quality of drugs and cosmetics circulating, stored, and used in the area, contributing to improving the effectiveness of treatment and healthcare for the people.

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