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USP Microbiology General Chapters and Dietary Supplements ...

USP Microbiology General Chapters and Dietary Supplements18 November 2020 Kit Goldman, , DirectorDietary Supplements and Herbal Tirumalai, , Principal Scientific Liaison2 2018 USPA genda Introduction to USP Utility of USP standards Compendial Hierarchy USP Microbiology Chapters Suitability Testing New Chapter <60>3 2018 USPWho We Are?4 2018 USPUSP COMPENDIAH ello, userGo to access the PF5 2018 USPR eference Standards Directly Linked to MonographsID TestsImpurity TestsRelated CompoundsLimit TestsResidual SolventsAssayDissolution 6 2017 USPThe Value of Public Standards6 2018 USP Provides scientific basis for decision making Ensures a consistent approach to quality Useful for monitoring of counterfeit and substandard products and quality Appropriate titles Useful definitions Validated methods Established limitsPractitioner/PatientUphold practitioner and patient confidence in the quality of their supplementsIndustryDietary supplement and ingredient manufactures produce quality productsGovernmentRegulators ensure quality products reach consumers7 Value of public standards in DS&HM8 2018 USPA dvantages to Compliance with USP Standards Supply Chain Transparency Ingredient supplier and purchaser understand the quality of the materials purchased when using USP materials Easier

Their analytical procedures ... Validation or Method Suitability Compendial microbiology test methods are growth-based methods which require that any microorganisms present be capable of growth in the presence of the article under test ... A Regulatory Perspective Dr. S.

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