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
Zhamashe a A.B.
Se ikbaye a E.A.
Zhakipbeko K.S.
Kazakh na ional medical uni e si y named by S. D. As endiya o , Alma y ci y,
Republic o Kazakhs an
e-mail: [email p o ec ed]
h ps://doi.o g/10.5281/zenodo.17332786
Rele ance: he de elopmen o he pha maceu ical indus y in he Alma y egion equi es he
in oduc ion o e ec i e quali y managemen sys ems based on in e na ional GMP s anda ds. This is
due o he need o ensu e he sa e y and e ec i eness o medicines, as well as Kazakhs an's in eg a ion
in o he egula o y space o he EAEU.
Pu pose o he s udy: o conduc a compa a i e analysis o he exis ing quali y managemen
sys ems a pha maceu ical en e p ises in he egion: KFK "Medse ice Plus", LLP "Medop ik", LLP
"Kelun - Kazpha m", JSC "Nobel AFF".
Ma e ials and me hods: me hods o documen a y and compa a i e analysis o o icial
in o ma ion (company websi es, da a om egula o y au ho i ies and in e na ional o ganiza ions), as
well as expe assessmen o he compliance o quali y sys ems wi h GMP, ISO and Lean s anda ds
ha e been applied.
Resul s: he analysis showed ha en e p ises di e in he le el o ma u i y o quali y
managemen sys ems:
– KFC Medse ice Plus is mainly ocused on he dis ibu ion and s o age o medicines. The
company has implemen ed he GDPR/GPP s anda ds o ensu e he sa e y o logis ics and he sa e y
o p oduc s a all s ages o supply. The ad an age is a wide dis ibu ion ne wo k and a high le el o
au oma ion o wa ehouse p ocesses.
– Medop ik LLP p oduces oph halmic d ugs, an isep ics and medical de ices. GMP and
HACCP elemen s a e implemen ed he e, which ensu es con ol o c i ical poin s and a high deg ee
o p oduc sa e y. The ad an age o he company is he p esence o i s own quali y con ol labo a o y
and a na ow specializa ion ha allows i o ocus on inno a ion in i s niche.
– Kelun–Kazpha m LLP uses GMP, ISO 9001 and mode n p oduc ion con ol me hods. The
plan is cha ac e ized by a high deg ee o p ocess au oma ion and he use o ad anced echnologies,
which educes p oduc ion isks. The ad an age o he company is he a ailabili y o in e na ional
suppo om he Kelun G oup holding, which allows i o implemen global quali y s anda ds.
Howe e , he main challenge emains he high cos o p oduc ion and he need o cons an
in es men in mode niza ion.
– Nobel AFFA JSC combines GMP and Lean managemen app oaches. The company has a
wide ange o p oduc s, sus ainable p oduc ion p ocesses and a high le el o expo po en ial. The
ad an ages a e a well-de eloped sys em o in e nal co po a e s anda ds, e ec i e use o lean
manu ac u ing p inciples and a high le el o s a aining. The main disad an age is he need o
la ge inancial expendi u es on he in oduc ion o inno a i e echnologies and main aining
compe i i eness in he in e na ional ma ke .
Conclusions: quali y managemen sys ems in he egion ha e di e en le els o de elopmen :
Kelun-Kazpha m LLP and Nobel AFF JSC ha e he mos ma u e ones, while Medse ice 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
Medop ic LLP need o s eng hen con ol p ocedu es and in es men s. A common challenge o all
en e p ises emains he need o con inuous imp o emen o in as uc u e and s a aining in
acco dance wi h GMP equi emen s.
