Minh Dan Pharmaceutical Joint Stock Company Expands and Upgrades Its Testing Laboratory – Strengthening Quality Control Capabilities in Alignment with International Standards

Minh Dan Pharmaceutical Joint Stock Company Expands and Upgrades Its Testing Laboratory – Strengthening Quality Control Capabilities in Alignment with International Standards

1. Quality Control – The Foundation of High-Quality Pharmaceutical Products

    In the pharmaceutical industry, quality is the decisive factor for therapeutic efficacy and patient safety. Therefore, alongside investment in modern production lines, the quality control system plays a pivotal role in ensuring that every raw material, semi-finished product, and finished product undergoes rigorous testing before entering production or being released to the market.

     Minh Dan’s Quality Control Department carries out a comprehensive range of activities, including the testing of raw materials, packaging, semi-finished goods, and finished products; water system testing; production environment monitoring; product stability studies; analytical method validation; OOS (Out-of-Specification) investigations; and support for research and development as well as drug registration. This department serves as a vital link in the quality assurance system, contributing to the consistent quality and reliability of every product batch.

2. Investing in the expansion of facilities and modern equipment systems.

       To meet testing requirements for an increasingly diverse range of dosage forms—such as large-volume infusions, lyophilized injections, injectable powders, tablets, film-coated tablets, capsules, powders, effervescent tablets, effervescent sachets, and oral solutions—Minh Dan has continued to invest in expanding its Quality Control Laboratory with several key upgrades.

        During this period, the company commissioned an additional physicochemical testing laboratory and expanded its microbiology testing area. It also invested in isolator systems for sterility testing and the weighing and preparation of anti-cancer active ingredients, thereby enhancing control capabilities for products with stringent technical requirements.

        Furthermore, the analytical equipment inventory has been continuously upgraded with state-of-the-art instruments—including HPLC and GC systems from renowned manufacturers like Agilent, Shimadzu, and Hitachi, alongside other world-class equipment for physicochemical, microbiological, and environmental monitoring tests. All equipment undergoes periodic validation, calibration, and maintenance in accordance with GMP regulations to ensure accuracy, reliability, and operational readiness.

       Agilent Gas Chromatograph:

       As part of its development strategy for the 2026–2030 period, alongside investments in high-tech production lines, Minh Dan Pharmaceutical Joint Stock Company is continuing to expand and upgrade its Quality Control (QC) Laboratory to strengthen its quality control capabilities. The investment in expanding the physicochemical and microbiological testing areas, coupled with the acquisition of advanced analytical equipment, represents a key step in the company's roadmap to enhance testing capacity, meet international GMP standards, and support its sustainable development strategy.

Agilent HPLC system

HPLC systems from Agilent and Hitachi:

Metrohm Karl Fischer and potentiometric titration instruments

Melting point apparatus and centrifuges:

Microbiological incubator

          Dissolution tester:

PH meter:

3. Operates in accordance with quality management systems and international standards:

       Alongside investments in facilities, Minh Dân places great emphasis on establishing and maintaining a comprehensive quality management system. The Quality Control Laboratory operates based on Standard Operating Procedures (SOPs) developed to meet GMP-WHO requirements, while also referencing guidelines from ICH, USP, BP, EP, JP, and the Vietnamese Pharmacopoeia, as well as environmental control standards under ISO 14644.

     The laboratory staff are well-trained and possess relevant expertise; they regularly participate in specialized training programs to stay updated on new regulatory requirements and advancements in the field of pharmaceutical testing. This commitment is crucial to upholding the quality, objectivity, and reliability of testing results.

4. Enhancing testing capabilities and aiming for advanced GMP standards

      The development of new production lines—particularly those for sterile and high-tech pharmaceuticals—places increasingly stringent demands on quality control. Consequently, expanding and upgrading the testing laboratory not only meets current needs but also establishes a foundation for the company's long-term growth.

      In the near future, Minh Dan will continue to invest in state-of-the-art analytical equipment and expand its testing capabilities for dosage forms with stringent technical requirements. The company will also progressively implement digital transformation and automation in quality management, while striving to better meet the requirements of EU GMP, PIC/S GMP, and international testing standards, thereby enhancing competitiveness and supporting market expansion goals.

5. Looking towards the future

         For Minh Dan Pharmaceutical Joint Stock Company, investing in the Testing Laboratory represents more than just an investment in facilities or modern equipment; it is an investment in quality, science, and sustainable development.

         Driven by a commitment to continuous innovation, the company will continue to refine its testing laboratory system, enhance the professional expertise of its workforce, invest in advanced analytical technologies, and build an increasingly modern quality management system. This serves as a vital foundation for Minh Dan to continue delivering high-quality, safe, and effective pharmaceutical products that meet the rising expectations of patients, partners, and regulatory authorities, while simultaneously affirming the standing of Vietnamese pharmaceuticals in the process of international integration.

        Minh Dan will continue to invest in and upgrade its testing laboratory system, providing updates on further developments in future articles.