Validaion01过程能力确认.ppt

Validation Validation Objectives of Part 1 To provide an introduction to the subject of Validation To provide information on the Validation Master Plan Validation Introduction Three basic principles of Quality Assurance: Quality, safety, effectiveness Cannot inspect quality into a product Processes must be under control Validation WHO validation definition The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.? Validation Qualification or validation?  A system must be qualified to operate in a validated process Qualify a system and/or equipment Validate a process Qualification versus validation, e.g. you qualify an autoclave, whereas you validate a sterilization process Validation Qualification and validation work require: Collaboration of experts Budget Meticulous and careful planning Validation Validation Master Plan Recommendation only Cover manufacturer’s validation policy and needs Provides information on validation organization It should describe: why? what? where? Validation Validation Master Plan Prospective validation Concurrent validation Retrospective validation Revalidation Change control Validation The VMP helps: Management Validation team members Project leaders GMP inspectors Validation The VMP Identifies validation items (products, processes, systems) Defines nature and extent of testing expected Outlines test procedures and protocols Summary document Management agreement Validation Validation Activities in VMP Every validation activity included Revalidation Validation of new process cycles Large validation projects have separate VMPs Include reasonable unexpected events Validation The VMP: Enables overview of entire validation project Lists items to be validated with the planning schedule as its heart Is like a map Validation The “Introduction” to the VMP Validation policy Project scope Location an