DEVELOPMENT OF ORGANIZATIONAL DESIGN MEASURES FOR QUALITY CONTROL OF PACKAGING MATERIALS FOR MEDICINES IN ORDER TO IMPROVE THEIR CONSUMER PROPERTIES

Abstract

Aim. Development of organizational design measures for quality control processes of packaging materials for medicinal products in order to improve their consumer properties.

Material and methods. The research methodology was based on Federal Law No. 61-FZ dated April 12, 2010, "On the Circulation of Medicines," and GOST R ISO 15378-2017, "Primary Packaging Materials for Medicines. Private Requirements for the Application of ISO 9001:2008, Taking into Account Good Manufacturing Practices (GMP)." The research objects were pharmaceutical enterprises: Sanofi Vostok JSC (Oryol Region), ORTAT JSC (Kostroma Region), Yuzhfarm LLC (Krasnodar Territory), and Farmera LLC (Ryazan Region).

Results. The developed organizational design measures for packaging materials quality control processes contribute to: transparency of processes and results (full documentation of all stages, the possibility of audit and verification, compliance with international standards, regular validation of methods); optimization of control procedures (elimination of duplicate checks; optimization of the sequence of operations, parallel execution of independent tests, standardization of techniques); acceleration of the process decision-making (instant access to test results, automatic verification of compliance with specifications, notification system for critical deviations, electronic approval of decisions, mobile access for key employees); improved traceability (the ability to quickly track history, optimize supply chain management, reduce the time to investigate deviations, improve the effectiveness of corrective actions); optimization of the error prevention system (visual status indicators, warning and reminder system, blocking potentially dangerous actions, double verification of critical operations,  a feedback system for continuous improvement), competitiveness in terms of consumer properties.

Conclusion. Quality control optimization measures contribute to comprehensive multi-level control of packaging materials at all stages, from incoming control to final inspection, ensuring high product quality and compliance with regulatory requirements in the pharmaceutical industry.