Q06-3200 Facility-Equipment – Design Requirements

The relationship with the Project Vendor should start at the design phase.

Some the typical SOPs for the Design stage includes:
– URS (User Requirement Specification)
– Suitable material of construction

NOTE:

This sub-category Facility & Equipment Requirements do share common templates as in E03-5000 Project Quality System (GEP):

To Open-Download-Print the PDF flowchart –>  E03-50-00_Project_Quality_Sys_Flowchart

E03-5000 Project Quality System Flowchart – Design

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  E03-5101 PROJECT DOCUMENTATION & TESTING REQUIREMENTS

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  E03-5201 Material Specifications for GMP Projects

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  E10-0101 PURIFIED WATER SYSTEM – DESIGN INPUT INFORMATION

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  E10-0102 DESIGN GUIDELINES FOR WATER-FOR-INJECTION WFI

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  E10-0103 PURIFIED WATER SYSTEM – CAPACITY ESTIMATE

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  E20-51 FACILITY DESIGN – GMP/GEP CHECKLIST (SAMPLE LIST)

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  E20-53 FACILITY DESIGN – GMP/GEP CHECKLIST – HVAC

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  E20-54 FACILITY DESIGN – GMP/GEP CHECKLIST – PROCESS EQUIPMENT

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  E20-55 FACILITY DESIGN -GMP/GEP CHECKLIST -PROCESS & UTILITIES

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