INTRODUCTION Project Description What is a Validation Master Plan Scope of a Validation Master Plan Definition of the Term Validation Validation Team Members Validation Team Responsibilities CONCEPT OF QUALIFICATION / VALIDATION Fundamentals Concept of a Validation Life Cycle Elements of Qualification/Validation Documentation Format of Qualification Programs Numbering System REVALIDATION RESPONSIBILITIES FACILITY DESCRIPTION Line Capacities DESCRIPTION OF BUILDING Dry Production Facility: Building A Liquid and Semisolid Production Facility: Building B Parenterals Production Facility: Building C EQUIPMENT DESCRIPTION Dry Production Facility: Building A Liquid and Semisolid Production Facility: Building B Parenterals Production Facility: Building C Over- Printing Area Quality Control Quality Assurance (In-Process) Product Development Laboratories HVAC DESCRIPTION Dry Production Facility: Building A Liquid and Semisolid Production Facility: Building B Parenterals Production Facility: Building C Over-Printing Area Quality Control Quality Assurance (In-Process) Product Development Laboratories UTILITIES DESCRIPTION Deionized Water (DI Water) Purified Water Water for Injection (WFI) Chilled Water Pure Steam Compressed Air Nitrogen (N2) Carbon Dioxide (CO2) Electric Power Sanitary Water HVAC (Heating, Ventilation, and Air Conditioning) System VALIDATION PROGRAM OVERVIEW Validation Project Management: Organization Validation Responsibilities Design and Validability Review Validation Documents Installation Qualification Protocols Operational Qualification Protocols Change Control Initiation Cycle Development Performance Qualification Protocols Process Validation Protocols Validation Final Reports Validation Package Certificate for Use in Manufacturing Required Protocols and Procedures for Dry Production: Building A Required Protocols and Procedures for Liquid and Semisolid Production: Building B Required Protocols and Procedures for Parenterals Production: Building C CALIBRATION PROGRAM SUMMARY PREVENTATIVE MAINTENANCE PROGRAM SUMMARY KEY STANDARD OPERATING PROCEDURES (SOPS) VALIDATION OF BUILDING Civil Work Drainage System VALIDATION OF UTILITY SYSTEMS Plant Steam Pure Steam Water for Injection (WFI) Compressed Air Nitrogen (N2) Heating Ventilation and Air Conditioning (HVAC) Emergency Power (Standby Generator) PROCESS DESCRIPTION BUILDING A DRY PRODUCTION: BUILDING A Process Flow, Variables and Responses: Tablets Process Flow, Variables and Responses Powder for Suspension Process Flow, Variables and Responses: Capsules PROCESS DESCRIPTION LIQUID AND SEMISOLID PRODUCTION: BUILDING B Process Flow, Variables, and Responses: Syrup, Suspension, and Drop Products Process Flow, Variables and Responses: Cream Ointment, and Suppository Products PROCESS DESCRIPTION FOR PARENTERALS PRODUCTION FACILITY: BUILDING C Process Flow, Variables, and Responses: Aseptic Fill Products Process Flow, Variables, and Responses: Ready-to-Use Disposable Syringes Process Flow, Variables, and Responses: Terminal Sterilization Products Process Flow, Variables and Responses: Lyophilized Products QUALIFICATION OF PROCESS EQUIPMENT Commuting Mill Dryer V-Shell Blender Tablet Compression Capsulation Powder Filing Capsule Polisher Tablet Coating Syrup Manufacturing Vessel Suspension Manufacturing Vessel Drops Manufacturing Vessel Mixer Filter Press Cream/Ointment/Suppository Manufacturing Vessel Syrup, Suspension, and Drop Filling Machine Cream and Ointment Filling Machine Suppository Filling Machine Labeling Machine Capping Machine Cartonator Shrink-Wrapping Machine Over-Printing Machine Autoclave (Steam Sterilizer) Hot Air Tunnel (Dry Heat Sterilizer) Vials / Ampoules Washing Machine Vials / Ampoules / Syringes Filling Machine Freeze Dyer (Lyophilizer) Laminar Flow Unit Pass Through VALIDATION OF SUPPORT PROCESS Washing of Components Sterilization of Components Depyrogenation of Components Aseptic Filling Validation (Media Fill Studies) Cross-Contamination Control Computerized Pharmaceutical System QUALITY ASSURANCE / CONTROL LABORATORY VALIDATION Laboratory Equipment Qualification Computer Related Systems in QA/QC Laboratory cGMP PROCEDURES AND PROGRAMS Engineering Change Control Calibration Preventive Maintenance Program Standard Operating Procedure (SOPs) Facility Cleaning and Sanitization Environmental Monitoring Program HEPA Filter Integrity Testing Filter Integrity Testing Label Control Program cGMP Training Equipment Log Book, Status Tags, and Room Clearance Checklists Validation Files VALIDATION SCHEDULE DRAWINGS FOR ABC PHARMACEUTICAL PLANT Indexea Quality Control Quality Assurance (In-Process) Product Development Laboratories HVAC DESCRIPTION Dry Production Facility: Building A Liquid and Semisolid Production Facility: Building B Parenterals Production Facility: Building C Over-Printing Area Quality Control Quality Assurance (In-Process) Product Development Laboratories UTILITIES DESCRIPTION Deionized Water (DI Water) Purified Water Water for Injection (WFI) Chilled Water Pure Steam Compressed Air Nitrogen (N2) Carbon Dioxide (CO2) Electric Power Sanitary Water HVAC (Heating, Ventilation, and Air Conditioning) System VALIDATION PROGRAM OVERVIEW Validation Project Management: Organization Validation Responsibilities Design and Validability Review Validation Documents Installation Qualification Protocols Operational Qualification Protocols Change Control Initiation Cycle Development Performance Qualification Protocols Process Validation Protocols Validation Final Reports Validation Package Certificate for Use in Manufacturing Required Protocols and Procedures for Dry Production: Building A Required Protocols and Procedures for Liquid and Semisolid Production: Building B Required Protocols and Procedures for Parenterals Production: Building C CALIBRATION PROGRAM SUMMARY PREVENTATIVE MAINTENANCE PROGRAM SUMMARY KEY STANDARD OPERATING PROCEDURES (SOPS) VALIDATION OF BUILDING Civil Work Drainage System VALIDATION OF UTILITY SYSTEMS Plant Steam Pure Steam Water for Injection (WFI) Compressed Air Nitrogen (N2) Heating Ventilation and Air Conditioning (HVAC) Emergency Power (Standby Generator) PROCESS DESCRIPTION BUILDING A DRY PRODUCTION: BUILDING A Process Flow, Variables and Responses: Tablets Process Flow, Variables and Responses Powder for Suspension Process Flow, Variables and Responses: Capsules PROCESS DESCRIPTION LIQUID AND SEMISOLID PRODUCTION: BUILDING B Process Flow, Variables, and Responses: Syrup, Suspension, and Drop Products Process Flow, Variables and Responses: Cream Ointment, and Suppository Products PROCESS DESCRIPTION FOR PARENTERALS PRODUCTION FACILITY: BUILDING C Process Flow, Variables, and Responses: Aseptic Fill Products Process Flow, Variables, and Responses: Ready-to-Use Disposable Syringes Process Flow, Variables, and Responses: Terminal Sterilization Products Process Flow, Variables and Responses: Lyophilized Products QUALIFICATION OF PROCESS EQUIPMENT Commuting Mill Dryer V-Shell Blender Tablet Compression Capsulation Powder Filing Capsule Polisher Tablet Coating Syrup Manufacturing Vessel Suspension Manufacturing Vessel Drops Manufacturing Vessel Mixer Filter Press Cream/Ointment/Suppository Manufacturing Vessel Syrup, Suspension, and Drop Filling Machine Cream and Ointment Filling Machine Suppository Filling Machine Labeling Machine Capping Machine Cartonator Shrink-Wrapping Machine Over-Printing Machine Autoclave (Steam Sterilizer) Hot Air Tunnel (Dry Heat Sterilizer) Vials / Ampoules Washing Machine Vials / Ampoules / Syringes Filling Machine Freeze Dyer (Lyophilizer) Laminar Flow Unit Pass Through VALIDATION OF SUPPORT PROCESS Washing of Components Sterilization of Components Depyrogenation of Components Aseptic Filling Validation (Media Fill Studies) Cross-Contamination Control Computerized Pharmaceutical System QUALITY ASSURANCE / CONTROL LABORATORY VALIDATION Laboratory Equipment Qualification Computer Related Systems in QA/QC Laboratory cGMP PROCEDURES AND PROGRAMS Engineering Change Control Calibration Preventive Maintenance Program Standard Operating Procedure (SOPs) Facility Cleaning and Sanitization Environmental Monitoring Program HEPA Filter Integrity Testing Filter Integrity Testing Label Control Program cGMP Training Equipment Log Book, Status Tags, and Room Clearance Checklists Validation Files VALIDATION SCHEDULE DRAWINGS.