Analysis of regulatory requirements for incoming quality control of cosmetic products in pharmacies

In modern pharmaceutical practice, cosmetic products occupy an important place in the assortment of pharmacies. However, current Ukrainian legislation does not contain clear requirements for their acceptance, which creates risks to the safety and legality of their distribution. The relevance of the study is determined by the need to harmonize national practice with European standards, as well as to develop internal algorithms for quality control. Aim of the study is to develop and substantiate an algorithm for incoming quality control of cosmetic products in Ukrainian pharmacies and to propose a conceptual model the “Quality Funnel” as a decision support tool for authorized persons. The study employed regulatory documents analysis, a review and analytical method, and a systems approach. The systematic analysis of the Technical Regulation on cosmetic products has highlighted the pivotal role of the responsible person in ensuring product compliance with safety and quality requirements. Furthermore, the significance of international GMP standards (ISO 22716:2015) and the provisions of Regulation (EC) No 1223/2009, which are gradually being implemented in Ukraine, was also emphasized. Statistical data confirm the steady growth of cosmetic sales in pharmacies: compared with the previous year, sales increased by 48 % in 2023, by 21.5 % in 2024, and by more than 15% in 2025. As of July 2026, the electronic notification system had registered over 14,500 cosmetic products and 800 responsible persons. An algorithm for visual inspection of cosmetic products in pharmacies by authorized person has been proposed. It includes verification of accompanying documents, packaging, labeling, expiry date, and accompanying information, which were not previously clearly regulated by normative documents. Key control parameters have been identified: integrity of packaging, absence of damage, batch number, expiration date, and others. A conceptual model, the “Quality Funnel,” has been developed to systematize acceptance procedures and transform them into a multilevel filtration process. The proposed algorithm and conceptual model of the “Quality Funnel” may be used as a decision support tool for authorized persons in pharmacies. Their practical implementation may contribute to the harmonization of national pharmaceutical practice with European requirements and improve the effectiveness of quality management systems in pharmacies.

Authors

Publication Details

Journal
Farmatsevtychnyi zhurnal
Published
2026-10-28
DOI
https://doi.org/10.32352/0367-3057.5.26.03
Primary Topic
Medical and Pharmaceutic Studies
Type
article
Field-Weighted Citation Impact
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article

Analysis of regulatory requirements for incoming quality control of cosmetic products in pharmacies

АНДРІЙ ЗЕЛІНСЬКИЙ, L. F. Prosianyk, Вікторія Іванівна Міщенко
Farmatsevtychnyi zhurnal
Medical and Pharmaceutic Studies
article

Analysis of regulatory requirements for incoming quality control of cosmetic products in pharmacies

АНДРІЙ ЗЕЛІНСЬКИЙ, L. F. Prosianyk, Вікторія Іванівна Міщенко
article en

Abstract

In modern pharmaceutical practice, cosmetic products occupy an important place in the assortment of pharmacies. However, current Ukrainian legislation does not contain clear requirements for their acceptance, which creates risks to the safety and legality of their distribution. The relevance of the study is determined by the need to harmonize national practice with European standards, as well as to develop internal algorithms for quality control. Aim of the study is to develop and substantiate an algorithm for incoming quality control of cosmetic products in Ukrainian pharmacies and to propose a conceptual model the “Quality Funnel” as a decision support tool for authorized persons. The study employed regulatory documents analysis, a review and analytical method, and a systems approach. The systematic analysis of the Technical Regulation on cosmetic products has highlighted the pivotal role of the responsible person in ensuring product compliance with safety and quality requirements. Furthermore, the significance of international GMP standards (ISO 22716:2015) and the provisions of Regulation (EC) No 1223/2009, which are gradually being implemented in Ukraine, was also emphasized. Statistical data confirm the steady growth of cosmetic sales in pharmacies: compared with the previous year, sales increased by 48 % in 2023, by 21.5 % in 2024, and by more than 15% in 2025. As of July 2026, the electronic notification system had registered over 14,500 cosmetic products and 800 responsible persons. An algorithm for visual inspection of cosmetic products in pharmacies by authorized person has been proposed. It includes verification of accompanying documents, packaging, labeling, expiry date, and accompanying information, which were not previously clearly regulated by normative documents. Key control parameters have been identified: integrity of packaging, absence of damage, batch number, expiration date, and others. A conceptual model, the “Quality Funnel,” has been developed to systematize acceptance procedures and transform them into a multilevel filtration process. The proposed algorithm and conceptual model of the “Quality Funnel” may be used as a decision support tool for authorized persons in pharmacies. Their practical implementation may contribute to the harmonization of national pharmaceutical practice with European requirements and improve the effectiveness of quality management systems in pharmacies.

Farmatsevtychnyi zhurnal(5)
Good health and well-being
Openalex Percentile: Top 10%
Medical and Pharmaceutic Studies
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