T/SHQAP 017-2024 Biopharmaceutical factory design GMP compliance guidelines

Scope

Main Technical Content: This standard integrates various information resources, unifies implementation standards, and provides clear design requirements for biomedical enterprises and related design units. It also facilitates early intervention by regulatory authorities in the design of standardized biomedical industry plants, strengthens risk prevention and control capabilities, enhances regulatory efficiency, and promotes high-quality development of new productivity in Shanghai's biomedical industry. I. General Provisions This section introduces the general principles of GMP-compliant design for biomedical plants, and elaborates on the overall design requirements from the perspectives of production and manufacturing areas, storage areas, quality control areas, and auxiliary areas. The production and manufacturing area is the core area of standardized biomedical plants, so the risk management of this area is described separately in this chapter, stipulating that the scope of risk assessment includes but is not limited to material product characteristics, process features, route planning, co-production situations, pest/rodent control, and advanced manufacturing technology requirements. II. General Requirements This section introduces the general requirements for GMP-compliant design of biomedical plants. According to the Pharmaceutical GMP (revised in 2010), biomedical standard plants are divided into production and manufacturing areas, storage areas, quality control areas, and auxiliary areas, and are regulated one by one. 1) Production and Manufacturing Area This section proposes the design principles of the production and manufacturing area, namely that the plant, production facilities, and equipment should meet the requirements of drug production, process flow, and corresponding cleanliness levels, with the aim of reducing contamination and cross-contamination. Subsequently, the corresponding design requirements of the production and manufacturing

Development Information

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