欧美设计确认模板val-055_design_qualification_guidelines_sample.pdfVIP

Standard Operating Procedure Title: Design Qualification Guidelines responsibilities for both the technical and cGMP compliance review of the design should be clearly mandated. It is crucial to start off with a User Requirement Specification (URS) for the project. It ensures that the user has defined exactly what is required, by specify operating and output requirements, any critical control requirements and any internal and regulatory standards, which may apply. All Requirement Specification documents should be approved by appropriate stakeholders including the quality group for GMP compliance, and used as primary referenced document in the design review process. See SOP VAL-030. Once compiled, this information will provide the project team with a basis for discussions and clarification of the system through the design phase of the project and to enable functional specification to be drawn up and reviewed. 2.1. Design Qualification Process The Design Qualification process should address the following points: What will be reviewed? (Documented in Validation Plan or DQ protocol) What methods or approach will be followed? (Documented in Validation Plan or DQ protocol) List of documents to be reviewed and consulted (Documented in Audits report or in design review minutes) List of members involved in the DQ review session (Documented in Audits report or in design review minutes) Conclusions and actions required (Documented in DQ protocol) The level of Design Qualification applied to any design should be based on a consideration of the complexity and novelty (to the user) of each system, and the impact of each system on the pr