Validation standard operating procedures : a step-by-step guide for achieving compliance in the pharmaceutical, medical device, and biotech industries

VAL 100.00Introduction to ValidationVAL 200.00Fundamentals of Validation SOPs Validation Master Plan and Guideline for DQ, IQ, QQ, and PQ Design Qualification Guideline for Minimizing the Risk of Product Cross-Contamination by Air Handling SystemDesign Qualification Guideline for Minimizing the Risk of Cross-Contamination of Facility, Equipment, and Process Design Qualification Guideline for HVAC System of a Pharmaceutical PlantDesign Qualification for the Prevention of Contamination of Non-Sterile Pharmaceutical Products Design Qualification Guideline for Cross-Contamination and DecontaminationDesign Specifications for Process Water Design Specifications for Water for Injection Production and DistributionDesign Specifications for Purified Water (DIW) Production and DistributionDesign Specification for Pure Steam Production and DistributionVAL 300.00Validation GlossaryOrganization for ValidationRevalidationRetrospective ValidationValidation Change ControlVAL 400.00Calibration of Instruments Periodic Review of the Calibration Program Calibration and Validation EquipmentVAL 500.00Training on the JobGood Manufacturing Practices VAL 600.00Guidelines for Area Classification and Air Handling Guideline for Area Validation: Clean AreaAseptic Area Validation ProceduresMicrobiological Monitoring of Areas Used for Production of Solids, Semi-Solids, and LiquidsEfficiency Testing for DisinfectantsDrinking Water Purified WaterWater for Injection Validation of a Water System Oil-Free Compressed Air System Nitrogen Distribution SystemClean Steam Vacuum SystemValidation of an HVAC SystemVAL 700.00Validation of a Steam Sterilizer Hot Air Sterilization Tunnel Certification and Validation GuidelineFreeze Drier Ampule and Vial Washing MachineWashing, Sterilizing, and Drying Machine for Stoppers Ampule and Vial Filling Machine Media Fill Run Half-Automatic Inspection MachineAmpule Crack Detection Machine Laminar Flow InstallationsSterile Filtration ValidationCleaning Efficiency of Production Equipment for Parenterals VAL 800.00Kneading MachineOscillating Granulator Milling MachineFluid Bed DrierBlenderTablet PressMetal Check Device for TabletsTablet CoaterVAL 900.00Blistering Machine Blister Filling Machine Code ReaderSachetting MachineCartoning Machine Labeling Machine Check WeigherShrink Wrapping and Bundling Machine Tube Filling and Closing MachineLiquid Filling and Closing Machine Tablet Filling and Closing Machine VAL 1000.00Installation Qualification of Computerized EquipmentOperational Qualification of Computerized Equipment Performance Qualification of Computerized Equipment VAL 1100.00Validation of Microbiological Methods Validation of Analytical Methods VAL 1200.00Vendor CertificationVAL 1300.00Facility QualificationRecommended Reading