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: jamashevaalina@gmail.com
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.
