MODERN METHODS OF DRUG QUALITY CONTROL IN PHARMACEUTICS
Abstract
This article provides a systematic analysis of modern analytical and instrumental methods used in pharmaceutical quality control. The quality of a medicinal product is directly linked to its safety and efficacy, and ensuring the unity of these three factors constitutes the primary objective of international pharmaceutical practice. Over the past decade, high-performance liquid chromatography (HPLC), mass spectrometry, near-infrared spectroscopy (NIR), nuclear magnetic resonance (NMR), and real-time monitoring technologies have been widely implemented in manufacturing processes. The article also discusses the regulatory foundations of quality control within the frameworks of ICH, USP, EP, and the State Pharmacopoeia, the concept of Process Analytical Technology (PAT), and the impact of digital transformation on quality control. The findings demonstrate that the optimal combination of analytical methods and continuous process monitoring represents the most effective approach to ensuring consistent drug quality.
References
1. International Council for Harmonisation (ICH). (2022). ICH Q2(R2) Guideline: Validation of Analytical Procedures. Geneva: ICH Secretariat.
2. U.S. Food and Drug Administration. (2004). PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Rockville: FDA.
3. European Pharmacopoeia, 11th Edition. (2023). Council of Europe, Strasbourg. European Directorate for the Quality of Medicines & HealthCare (EDQM).
4. United States Pharmacopeia (USP 46). (2023). United States Pharmacopeial Convention. Rockville, MD.
5. Schweitzer, M., et al. (2010). Implications and opportunities of applying QbD principles to analytical measurements. Pharmaceutical Technology, 34(2), 52–59.
6. Bakeev, K. A. (Ed.). (2010). Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries (2nd ed.). Wiley-Blackwell.
7. De Beer, T., et al. (2011). Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. International Journal of Pharmaceutics, 417(1–2), 32–47.
8. Rozet, E., et al. (2011). Analysis of recent pharmaceutical regulatory documents on analytical method validation. Journal of Chromatography A, 1218(32), 5373–5383.
9. Simoens, S. (2011). Biosimilar medicines and cost-effectiveness. ClinicoEconomics and Outcomes Research, 3, 29–36.
10. Ministry of Health of the Republic of Uzbekistan. (2021). Regulation on the Procedure for Registration and Quality Control of Medicinal Products in the Republic of Uzbekistan. Tashkent: Ministry of Health Publishing House.