T/SHPPA 011-2021 Guidelines for the Supply Chain Management of Autologous CAR-T Cell Drugs

Scope

Scope: This document specifies the requirements for the supply chain management of autologous CAR-T cell drugs, including the responsibilities of drug marketing authorization holders and related parties in the supply chain of autologous CAR-T cell drugs, digital information platforms, facilities and equipment, logistics operations, donor materials and transportation of autologous CAR-T cell drugs, storage of autologous CAR-T cell drugs, delivery of autologous CAR-T cell drugs, handling of abnormal situations, recalls, disposal of non-conforming products, and document records, etc. This document applies to the supply chain management and services of autologous CAR-T cell drug marketing authorization holders, pharmaceutical distribution enterprises, pharmaceutical logistics enterprises, and medical institutions. This document can also be used as a reference for the implementation of supply chain management during the clinical trial phase of autologous CAR-T cell drugs. Main technical content: This document specifies the responsibilities of drug marketing authorization holders and related parties in the supply chain of autologous CAR-T cell drugs, clarifies key elements such as facilities and equipment, logistics operations, and informatization technology in the supply chain process of autologous CAR-T cell drugs, realizes full-process management among patients, medical institutions, drug marketing authorization holders, pharmaceutical logistics enterprises, and pharmaceutical distribution enterprises, and controls potential risks in the supply chain through full-process traceable quality supervision and efficient collaborative operation mode to ensure the safety and effectiveness of autologous CAR-T cell drugs.

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