Penerapan Quality by Design (QbD) sebagai Pendekatan Sistematis untuk Perancangan Proses Pengembangan Ekstrak Herbal
DOI:
https://doi.org/10.25170/jpk.v3i03.7913Keywords:
Quality by Design (QbD), Ekstrak, HerbalAbstract
Quality by Design (QbD) represents a paradigm shift in product development, moving away from the concept of quality by testing toward a systematic approach where quality is inherently built into the process. However, its application in the development of herbal extract products remains limited. This study aims to analyze the systematic implementation of QbD in herbal extract development by identifying the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA), as well as conductiong a comprehensive risk assessment that explains the causal relationships of Critical Material Attributes (CMA) and Critical Process Parameter (CPP) to the CQA. The results indicate that there are 10 CMAs and 6 CPPs that have impact medium-to-high risks to 7 CQAs of herbal extract. By implementing QbD, the industry can proactively deplot control strategies to mitigate potential process failures and variability, leading to a more robust, efficient, and reproducible process design for process design.
References
Atanasov, A. G., Zotchev, S. B., Dirsch, V. M. & Supuran, C. T. (2021). Natural products in drug discovery: advances and opportunities. Nature Reviews Drug Discovery, 20, 200-216.
Eapen, A. S., Bhosale, Y. K., & Roy, S. (2025). A review on novel techniques used for drying medicinal plants and its applications. International Journal of Biomaterials, Vol. 2025, 4533070.
Goodarzi, M., Russell, P. J., & Heyden, Y. V. (2013). Similarity analyses of chromatographic herbal fingerprints: a review. Analytica Chimica Acta, 804, 16-28.
Grand View Research. (2024). Herbal Medicine Market (2024-2030) (https://www.grandviewresearch.com/industry-analysis/herbal-medicine-market-report). Diakses tanggal 17 April 2026.
ICH. (2009). Pharmaceutical Development Q8(R2) (https://www.ich.org/page/quality-guidelines). Diakses pada 17 April 2026.
Li, Y., Shen, Y., Yao, C., & Guo, D. (2020). Quality assessment of herbal medicines based on chemical fingerprints combined with chemometrics approach: a review. Journal of Pharmaceutical and Biomedical Analysis, 185, 113215.
Mokaizh, A. A. B., Nour, A. H., Kerboua, K. (2024). Ultrasonic-assisted extraction to enhance the recovery of bioactive phenolic compounds from Commiphora gileadensis leaves. Ultrasonic Sonochemistry, 102, 106852.
WHO. (2023). WHO Traditional Medicine Global Summit 2023 (https://www.who.int/publications/m/item/who-traditional-medicine-global-summit-2023). Diakses 17 April 2026.
