美国药典及其食品补充剂认证体系.pptVIP

Off-the-Shelf Testing 市售产品测试 USP will continuously test and examine selected lots and marketplace samples of approved products to ensure that USP将持续测试和检查已批准产品的选择批号和市售样品, 以确保 The mark is being used in accordance with guidelines 标识按指南使用 The product continues to meet the criteria to carry the mark 产品持续标准,可以使用标识 The product has not been reformulated 产品没有重新加工 There have been no major changes in the manufacturing process, specifications, test methods, or any other critical quality parameters 在生产过程, 质量标准, 测试方法或其它关键参数上没有主要变更 USP Verified Dietary SupplementsUSP认证的食品补充剂 USP Dietary Ingredient Verification(IVP)美国药典食品补充剂原料认证 USP Dietary Ingredient Verification美国药典食品补充剂原料认证 Voluntary participation by ingredient manufacturers 原料生产商自愿参与 Verification of ingredients manufactured and marketed to the dietary supplement industry in the U.S. and worldwide 原料认证适于在美国和全球范围内生产和销售食品补充剂的企业 Ingredients covered by this program 认证涉及的原料包括： Vitamins 维生素 Minerals 矿物质 Amino acids 氨基酸 Powdered botanicals and botanical extracts 植物粉末和植物提取物 Other non-botanical dietary ingredients legally marketed under DSHEA (e.g. fish oil, chondroitin sulfate sodium, glucosamine, etc) 食品补充剂健康教育法包含的和在美国合法上市的非植物食品补充剂 （如鱼油，硫酸软骨素钠，葡糖胺等） GMP Audit of Manufacturing Sites生产场地的GMP检查 Audit for compliance with 审核依据 ICH Q7 Guideline Good Manufacturing Practices for Active Pharmaceutical Ingredients (Audit Criteria) ICH Q7 原料药良好生产管理规范指南 ( 现场审核标准) Benefits of USP Ingredient Verification USP原料认证项目价值 Improved systems to ensure ingredient quality and consistency 提高质量体系, 确保原料质量和一致性 Recognition among dietary supplement manufacturers 被食品补充剂产品生产商认可 Easy vendor qualification 简化供应商认证 Preferred vendor status 优选供应商地位 USP-verified ingredients reduce the level of testing for manufacturers USP认证的原料可以减少产品生产商的测试 Supplements containing USP-verified ingredients add to consumer confidence 采用USP认证原料的产品可以增加客户信任 USP Verified IngredientsUSP认证的食品补充剂原料 USP Verified Ingredients 通过USP