Received: 2 February 2026
Accepted: 12 February 2026
Published online: 27 February 2026
УДК: 615.1:658.562
DOI: 10.53511/pharmkaz.2026.1.4
ASSESSMENT OF STAFF READINESS AT A PHARMACEUTICAL ENTERPRISE TO
IMPLEMENT QUALITY STANDARDS AND SUSTAINABLE MANUFACTURING
PRACTICES: A CROSS-SECTIONAL STUDY USING QUANTITATIVE SWOT ANALYSIS
IN KAZAKHSTAN
Zhamasheva A.B.¹, Аlaydar Zh.А.¹, Serikbayeva E.A.¹, Zhakipbekov K.S.¹, Egizbayeva Sh.А.¹, Seitova Zh.D.¹
¹Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan
Abstract. In the context of the rapid development of Kazakhstan’s pharmaceutical sector and
increasingly stringent requirements for medicinal product quality, internal corporate quality
management standards and sustainable manufacturing practices are gaining growing importance. The effectiveness of implementing such changes largely depends on staff readiness-understanding the objectives, possessing the necessary competencies, and being able to comply with updated procedures. The international quality agenda further strengthens the role of risk-based quality management, as reflected in ICH Q9(R1), which aims to reduce subjectivity in risk assessments and improve the quality of risk-based decision-making to enhance process reliability and product availability [1,2]. The study is aligned with SDG 12 «Responsible Consumption and Production» which promotes resource efficiency and waste reduction [4].
Objective. To assess the readiness of employees of a pharmaceutical enterprise to implement internal corporate quality management standards and elements of sustainable manufacturing in line with SDG 12.
Materials and Methods. An observational cross-sectional questionnaire-based survey was
conducted among 100 employees from different departments of a pharmaceutical enterprise
(production, QA, QC, administrative unit, and logistics). Data were processed using Microsoft Excel. Staff readiness was assessed using a quantitative SWOT analysis with the calculation of weighted summary scores for the categories «strengths/weaknesses/opportunities/threats».
Results. The sample comprised 76% mid-level specialists, 7% managers, and 17% other staff
categories. Regarding work experience, 47% had less than 3 years, 31% had 3 – 5 years, and 22% had more than 5 years of experience. The overall SWOT scores were S=4.80, W=3.55, O=4.10, and
T=3.95, indicating that strengths and opportunities outweighed limitations and threats. Key strengths included a high level of GMP awareness and the perception of standards as a source of
competitiveness; major constraints were insufficiently regular training and limited use of digital
learning tools.
Scientific novelty. For the first time in the context of a Kazakhstani pharmaceutical enterprise, a
quantitative strategic measurement of staff readiness to implement quality standards and sustainablemanufacturing practices was proposed and piloted by integrating questionnaire data with a weighted SWOT approach.
The requirements of risk-based quality management (ICH Q9(R1)) were conceptually linked to staff
readiness as a factor influencing the quality of risk-based decisions and the sustainability of
implementation [1,2].
A practical operationalization of alignment with SDG 12 was proposed through a set of measurable
KPIs for resource efficiency and «responsible production» [4].
Conclusions. Overall, staff demonstrated a high level of readiness to implement quality and
sustainable manufacturing standards; however, sustaining these changes requires systematic training, expanded digital learning formats, and strengthened practical competencies in developing and updating internal standards.
Keywords: pharmaceutical industry; Kazakhstan; SDG 12; responsible production; sustainable
manufacturing; quality management; GMP; internal corporate standards; SWOT analysis; staff
readiness.
