【正文】 .........................................................................................12 PRODUCTION SUITES .............................................................................................................................12 Zone 1, NonSterile Manufacturing..............................................................................................................12 Zone 2, Preparation of Cytotoxic Products and Parental Nutrition Products.............................................12 EQUIPMENT AND SERVICES TO BE VALIDATED ...........................................................14 IMPACT ASSESSMENT.............................................................................................................................14 RISK ASSESSMENT.................................................................................................................................14 VALIDATION MATRIX ...............................................................................................................................14 VALIDATION ACTIVITIES ...................................................................................................15 VALIDATION ACTIVITIES ..........................................................................................................................15 User Requirement Specification (URS) ........................................................................................................15 Technical Specification ................................................................................................................................15 Impact Assessment........................................................................................................................................15 Design Review/Qualification........................................................................................................................15 Factory Acceptance Tests.............................................................................................................................15 Commissioning .............................................................................................................................................16 Installation Qualification .............................................................................................................................16 Calibration ...................................................................................................................................................16 Operational Qualification ............................................................................................................................17 Standard Operating Procedures ..............................................................................................................17 Performance Qualification ......................................................................................................................18 Combined Qualifications (I/OQ amp。 O/PQ) ...............................................................................................18 Process Validation (PV)...........................................................................................................................18 Cleaning Validation .................................................................................................................................18 Analytical Method and Laboratory Equipment Validation......................................................................19 Product Storage and Distribution Validation..........................................................................................19 Relocated Equipment ...............................................................................................................................19 Computer Validation Testing ...................................................................................................................205 / 32 Computer Operational Qualification.......................................................................錯誤！未定義書簽。 M Operation and MaintenanceBS British Standard OQ Operational QualificationCFR Code of Federal Regulations Pamp。 Design Statement SVA Small Volume AmpoulesGA General Arrangement TPN Total Parenteral NutritionGAMP Good Automated Manufacturing PracticeURS User Requirement StatementGCP Good Cleaning Practice VCC Validation Change ControlGEP Good Engineering Practice VMP Validation Master PlanGLP Good Laboratory Practice VSC Validation Steering CommitteeHACCP Hazard And Critical Control Point VTF Validation Technical FileHSamp。 M manuals for equipment/systems.? Approval of validation protocols for content relating to engineering content. Pharmacy Quality Control Officer? Ensuring appropriate Quality Control (QC) procedures are in place ? Provision and maintenance of auditable document storage systems.? Approval of validation protocols for quality aspects.? Approval of all working QC and production documents Validation Engineer? Identify and plan appropriate validation activities.? Provide validation technical support and training.? Ensure appropriate validation procedures are in place.10 / 32 INTRODUCTION Purposes of the VMPThe purposes of the VMP are to:? Identify the members of the Validation Steering Committee.? Identify Regulatory requirements.? Identify and describe the facility, systems and equipment to be validated.? Identify and describe products and processes to be validated.? Identify the validation activities that will be undertaken.? Identify the methods by which these activities will be undertaken.? Identify the documentation requirements to support the above activities. Overview of ProjectThis VMP relates to a new facility, to be known as the _______________________. In line with current GMP standards the new pharmacy will