Development of risk management processes for the quality of medicinal products in supply chains

Introduction. Advanced Therapy Medicinal Products (ATMP) are used for medical purposes and do not require external storage and transportation. In the context of supply chain risk management, the publication is currently not relevant. These gateways are transported in a closed or non-frozen environment. Cryopreservation is the gold standard for the storage and transportation of living cells; however, its impact on the quality of medicinal products remains unclear. Some safety issues are strictly addressed on an individual basis when transporting frozen cells: the materials used to produce the main container and the cryoprotective reagents used. In this regard, the development of approaches to managing logistics risks for ATMP is relevant for developing the ATMP market in Russia.

Objective. To develop criteria for assessing contractors and service providers in the market for circulating high-tech medicinal products by holders of registration certificates.

Materials and methods. The materials were the results of the analysis of the world and own scientific data and regulatory documents in the relevant field. General scientific methods, system and process approaches, and methods for analysis, synthesis, and extrapolation were applied.

Results. Risks arising in drug supply logistics chains were identified. The criteria for selecting a service provider for the transportation of ATMP and other heat-labile medicinal products for the holder of a registration certificate, applied to reduce the risks associated with logistics chains, are substantiated. Potential suppliers of transportation services for medicines are recommended based on the developed criteria. This study substantiates the development of recommendations for ATMP risk management for investors, pharmaceutical manufacturers and distributors for ATMP production and implementation localization.

Conclusions. Risks arising during the transportation and storage of medicinal products requiring special storage conditions were investigated. The risk management of medicinal products at the distribution stage requires a comprehensive approach.

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