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Zusatztext "This book may therefore become a useful tool to further the implementation of more "modern" approaches towards product safety and quality and to actually help transitioning dietary supplements to become food also in real life and not only from a regulatory stand point."-Elena Vittadini! International Journal of Food Science and Nutrition"Bill Mead's primer Dietary Supplement Good Manufacturing Practices - Preparing for Compliance! should be required reading for every quality control department in the supplement industry. The book dissects and digests the FDA's lengthy regulations and preamble! making the minutiae of a very complicated rulemaking understandable so the requirements can actually be implemented. Bill Mead offers not only "what" the rule requires but "how" to comply! and "why" each topic is critical to pass your next inspection. Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door."-Steve Mister! President & CEO! Council for Responsible Nutrition Informationen zum Autor William J. Mead Klappentext Dietary Supplement Good Manufacturing Practices Zusammenfassung Dietary Supplement Good Manufacturing Practices Inhaltsverzeichnis The Basics of Good Manufacturing PracticeRegulatory OverviewPersonnel MattersPhysical Plant and GroundsEquipment and UtensilsCleaning and SanitationMaintenance and GMPCalibrationProduction and Process ControlsSpecificationsSamplingDeviations and Corrective ActionsIncoming Components! Packaging Materials and LabelsMaster Manufacturing RecordBatch Production RecordManufacturing OperationsPackaging and Labeling OperationsQuality Control ResponsibilitiesLaboratory OperationsReturned GoodsProduct Complaint HandlingHolding and DistributingHandling RecallsTop Management ResponsibilityRecord Keeping! Documentation! SOPsChange ControlAdverse Event Reporting and Records KeepingContinuous ImprovementSupply Chain IntegrityAuditsOutsourcingThe FDAFDA Inspections ...
