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The Regulatory Basis for Process Validation
Validation of Sterile Products
Validation of Solid Dosage Forms
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acetaminophen active ingredient analysis analytical methods APPROVED aseptic assurance autoclave batch record biological indicator blend calibration cause-and-effect diagram certificates of analysis CGMP regulations challenge characteristics chemical coating compression container control charts control limits cool spot critical depyrogenate determine distribution documentation Drug Assoc drug products dry-heat endotoxin equipment established ethylene oxide evaluated example excipients experimental F0 value filter medium filtration flow friability granulation heat identified in-process incubation industry laboratory liquid load manufacturing practice manufacturing process measure microbial microorganisms monitoring nonsterile organisms parenteral particle performed personnel pharmaceutical pore potency powder pressure problems process validation product batch protocol qualification quality-control range retrospective validation samples scale-up Solid Dosage Form SOPs spore statistical steam sterilization sterile product sterilization cycle sterilization process sterilization validation storage supplier tablet weight temperature test procedures thermocouples tion validation program variation