T/CPHARMA 008-2024 Guidelines for the Quality Management of Intravenous Cellular Toxic Drug Dispensing in Medical Institutions (Second Edition)

Scope

Main technical content: This project stipulates the general principles, general requirements, safe operation, quality supervision, and spillage management of intravenous cytotoxic drug preparation, including environmental layout, equipment setup, personnel setup, document management, etc. It particularly clarifies the core procedures for intravenous cytotoxic drug preparation and the standard process for handling cytotoxic drug spillage. The environmental layout specifies the pressure gradient of each room in the preparation area, the cleanliness level of the preparation clean area and the requirements for air exchange frequency, room temperature and humidity, and air conditioning systems; the equipment setup clarifies the model of biosafety cabinets, the selection conditions for temporary storage and transfer containers of drugs, and the requirements for automated preparation equipment; the personnel setup clarifies the on-the-job standards and assessment systems; the document management sets out quality control systems and inspection records. The core procedures for intravenous cytotoxic drug preparation cover safety operation requirements and quality supervision requirements; the standard process for handling cytotoxic drug spillage clarifies the relevant operating procedures.

Development Information

Related Standards