PQ_Form_Template性能确认模版.docVIP

性能确认（PQ）表格 Name of Facility:_______________________________________________ page _ of _ Validation Protocol # _________ Performance Qualification Title Protocol written by Departmental Approval by Date ________________ QA Approval by Date ________________ Objective To determine that the systems/equipment perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications under normal conditions, and where appropriate for worst case situations. Scope 1-To be performed after the Installation and Operational Qualification have been completed and approved. 2-To be performed after installation, modification or relocation and for re-validation at appropriate intervals. 3-Each piece of equipment must be validated before it serves another piece of equipment/system during validation of the latter (e.g. water system before steam generator; steam generator before autoclave).  Validation Protocol________________________ Performance Qualification ___page ___ of ___ Title ___________________________ Name of Facility _________________________________ Responsibility 1-Person responsible for operating the system or equipment will perform the qualification and record the information. 2-The supervisor will supervise the study, verify the completion of the records and write the Deviation Report and the Performance Qualification Report. 3-Quality Assurance will review and approve the Performance Qualification Protocol and Report. Materials, Equipment, Documents SOPs for normal operations of the equipment or system under test (including data record forms, charts, diagrams materials and equipment needed). Attach copies. SOP list: _______________________________________________________________________ _______________________________________________________________________________ ___