1. PPURS (project and product URS) for a newplant or renovated workshop
For this type of the URS, the main purpose is to comprehensively collect the needs of management at all levels for a new project and avoid any omissions. The output can support a design party or institute in a greatextent to conduct a comprehensive plant design. The content commonly covers description of:
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Project general introduction, product and service planning, etc.
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Specific needs, such as GMP requirements, e.g., risk-related requirements, GMP key concepts e.g., design, operation,qualification and validation concepts, process key data, personnel and materials flow,premises and facilities, equipment and systems, automation/softwarerequirements, cleaning concepts, documentation requirements, etc.
2. System or equipment URS
For this type of URS specific to a system or equipment, attention is paid to the GMP requirements, functions, materials, key process parameters, data management, document requirements and other aspects according to the system or equipment.
This kind of URS provides a basis for the design and procurement of specific systems or equipment, and can guide qualification and validation activities in the late stage. Therefore, the requirements written in the URS must be clear, quantifiable, and according to the demand. Users need to set the items from the perspective of product and process requirements, mainly considering GMP requirements and high-level process requirements and avoiding list the commercial and detailed designs in URS.
