In recent years, laboratory validation has emerged as a critical factor in obtaining licenses and ensuring the quality of pharmaceutical products, particularly in the herbal medicine sector. Experts believe that robust validation processes are essential for achieving regulatory approvals and entering international markets.
Growing Focus on Laboratory Validation in Herbal Drug Industry: A Key to Licensing and Export
According to a report by the Health Technology Development Center, over 70% of herbal drug license rejections are due to insufficient validation documentation and unreliable test methods.
Dr. F. Karimi, a pharmaceutical quality control expert, states:
"Without validation, even the most promising herbal formulations may never reach the market. The complexity of plant-based drugs makes validation even more crucial."
Investments in advanced laboratory technologies like HPLC, GC-MS, and FTIR, along with training specialized personnel, are key to establishing reliable validation systems. Moreover, integrating artificial intelligence in analytical data processing is improving precision in testing.
As the global demand for high-quality herbal products rises, companies—from startups to traditional manufacturers—must treat laboratory validation not just as a regulatory requirement, but as a competitive advantage.
