COMPARATIVE ANALYSIS OF EXISTING QUALITY MANAGEMENT SYSTEMS AT PHARMACEUTICAL ENTERPRISES OF THE ALMATY REGION

205 Volume 5, Issue 10: Special Issue (EJAR) ISSN: 2181-2020 MPHAPP THE 6TH INTERNATIONAL SCIENTIFIC AND PRACTICAL CONFERENCE “MODERN PHARMACEUTICS: ACTUAL PROBLEMS AND PROSPECTS” TASHKENT, OCTOBER 17, 2025 in-academy.uz COMPARATIVE ANALYSIS OF EXISTING QUALITY MANAGEMENT SYSTEMS AT PHARMACEUTICAL ENTERPRISES OF THE ALMATY REGION Zhamasheva A.B. Serikbayeva E.A. Zhakipbekov K.S. Kazakh national medical university named by S. D. Asfendiyarov, Almaty city, Republic of Kazakhstan e-mail: [email protected] https://doi.org/10.5281/zenodo.17332786 Relevance: the development of the pharmaceutical industry in the Almaty region requires the introduction of effective quality management systems based on international GMP standards. This is due to the need to ensure the safety and effectiveness of medicines, as well as Kazakhstan's integration into the regulatory space of the EAEU. Purpose of the study: to conduct a comparative analysis of the existing quality management systems at pharmaceutical enterprises in the region: KFK "Medservice Plus", LLP "Medoptik", LLP "Kelun - Kazpharm", JSC "Nobel AFF". Materials and methods: methods of documentary and comparative analysis of official information (company websites, data from regulatory authorities and international organizations), as well as expert assessment of the compliance of quality systems with GMP, ISO and Lean standards have been applied. Results: the analysis showed that enterprises differ in the level of maturity of quality management systems: – KFC Medservice Plus is mainly focused on the distribution and storage of medicines. The company has implemented the GDPR/GPP standards to ensure the safety of logistics and the safety of products at all stages of supply. The advantage is a wide distribution network and a high level of automation of warehouse processes. – Medoptik LLP produces ophthalmic drugs, antiseptics and medical devices. GMP and HACCP elements are implemented here, which ensures control of critical points and a high degree of product safety. The advantage of the company is the presence of its own quality control laboratory and a narrow specialization that allows it to focus on innovation in its niche. – Kelun–Kazpharm LLP uses GMP, ISO 9001 and modern production control methods. The plant is characterized by a high degree of process automation and the use of advanced technologies, which reduces production risks. The advantage of the company is the availability of international support from the Kelun Group holding, which allows it to implement global quality standards. However, the main challenge remains the high cost of production and the need for constant investment in modernization. – Nobel AFFA JSC combines GMP and Lean management approaches. The company has a wide range of products, sustainable production processes and a high level of export potential. The advantages are a well-developed system of internal corporate standards, effective use of lean manufacturing principles and a high level of staff training. The main disadvantage is the need for large financial expenditures on the introduction of innovative technologies and maintaining competitiveness in the international market. Conclusions: quality management systems in the region have different levels of development: Kelun-Kazpharm LLP and Nobel AFF JSC have the most mature ones, while Medservice Plus and 206 Volume 5, Issue 10: Special Issue (EJAR) ISSN: 2181-2020 MPHAPP THE 6TH INTERNATIONAL SCIENTIFIC AND PRACTICAL CONFERENCE “MODERN PHARMACEUTICS: ACTUAL PROBLEMS AND PROSPECTS” TASHKENT, OCTOBER 17, 2025 in-academy.uz Medoptic LLP need to strengthen control procedures and investments. A common challenge for all enterprises remains the need for continuous improvement of infrastructure and staff training in accordance with GMP requirements.