In the context of the ever-evolving pharmaceutical industry, evaluating drug quality has become increasingly critical, necessitating the use of appropriate methodologies, tools, and equipment. However, the diversity and complexity of pharmaceutical products have posed significant challenges for drug testing centers. This study focuses on analyzing the testing capabilities and actual requirements at the Da Nang Quality Control Center (DQCC) in 2021.

By retrospectively examining the testing records of DQCC in 2021, the study identifies several limitations and challenges faced by the center in testing tablet forms, injectable drugs, and medicinal herbs. The main issues include equipment shortages, lack of standardized materials, and insufficient availability of chemicals, resulting in a significant proportion of mandatory tests being unperformed. Specifically, 19.77% of the required tests for tablet forms could not be conducted, while injectable drugs faced greater difficulties with critical tests such as clarity, sterility, and pyrogen presence not performed on any samples.

Moreover, the testing capability for medicinal herbs at DQCC is significantly limited, with only 15.46% of samples tested, primarily due to shortages of equipment, necessary chemicals, and standards. These limitations are not unique to DQCC but are prevalent in many other testing centers. The study highlights the urgent need for investment and support from higher-level organizations to improve testing capabilities, ensure compliance with international standards, and guarantee pharmaceutical quality. Future research should focus on enhancing the testing capacity for tablet forms, injectable drugs, and medicinal herbs to meet the increasing demands and complexity of the pharmaceutical sector.

Người viết: Hà Hải Anh

Tham khảo: https://www.researchgate.net/publication/373871159