Amidst the modernization of the pharmaceutical industry, establishing a technology-driven “technical barrier” is becoming an essential standard. A leading Vietnamese pharmaceutical enterprise has implemented an integrated risk management system, covering the entire supply chain from international-standard medicinal cultivation to final product distribution.
Technological Highlights and Artificial Intelligence (AI):
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AI in Validation: Utilizing Artificial Intelligence combined with infrared spectroscopy data to classify medicinal herbs with an accuracy rate exceeding 99%. This technology enables the precise identification of plant parts (roots, stems) and the detection of impurities, eliminating errors caused by human sensory factors.
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Data Integrity: Laboratory systems operate on software platforms that meet the stringent 21 CFR Part 11 standards of the US FDA, ensuring that all operations are tracked and protected against unauthorized interference.
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Advanced Analytical Equipment: The use of in-situ UV fiber optics and online-connected liquid chromatography (HPLC/UHPLC) systems allows for real-time monitoring of dissolution rates and active ingredient compositions.
Strategic Development of Modern Medicines: In addition to traditional herbal strengths, the modern medicine sector is focusing on Bioequivalence (BE) research. This process proves that domestic drugs have a therapeutic efficacy of 80-125% compared to the original brand-name drugs while costing only 30-50% as much. By partnering in technology transfers with Korean medical corporations and upgrading manufacturing facilities to EU-GMP standards, the enterprise is gradually replacing expensive imported drugs with high-quality local products.