美国药典及其食品补充剂(成分)认证

1、United States Pharmacopeia and Verification Programs （Dietary Supplement and Ingredient） 美国药典及其食品补充剂（成分）认证胡江滨 博士Vice President, USP InternationalGeneral Manager，USP-China USPA Standards-setting Organization美国药典 一个致力于标准建立的组织Independent and unbiased. 独立公正Established in 1820. 188 years of experience in

2、 setting standards: prescription and OTC medicines, dietary supplements, and other healthcare products.成立于1820年, 具有188年建立涉及处方药品,非处方药品, 食品补充剂以及其它保健产品标准的经验USP standards: recognized by federal law in the U.S. and trusted worldwide used in over 130 countries.美国药典标准: 美国联邦法律认可的法定标准，全球130多个国家广受信赖USPs Verif

3、ication Programs美国药典认证计划USP is well known for its work with active pharmaceutical ingredients and dosage forms美国药典因其在药用原料和制剂领域的成就而闻名于世USP has been very active with botanicals, vitamins, minerals, and other supplements美国药典也积极致力于植物类, 维生素, 矿物质和其它补充剂的工作USP verification programs provide assurance of qual

4、ity from an independent unbiased third party assessment美国药典认证项目可以从一个独立公平的第三方评估的角度提供质量保证USP has set up sites in China, India and Brazil. Our global presence can can benefit the participants of the Verification Programs and help them to enter the global market.美国药典已在中国、印度和巴西设立分部,我们的全球化运作可以为参加认证的企业拓展国际

5、市场提供帮助。USPs Verification Programs美国药典认证计划 The Mark of Quality质量的标志Good quality medicines meet official standards for identity, strength, purity, quality, packaging, and labeling.意味着您的产品是在真伪性,规格,纯度,质量,包装和标签等方面符合官方标准的质量优良的药品Rigorous USP Verification Process严格的美国药典认证流程1. 下载并阅读参加者手册填写申请表Read Participant

6、 Manual.Submit Application Form审计前培训（可选）Audit Preparation Workshop(Optional)3. 按照参加者手册程序开始正式审核（文件、现场、样品）Formal Procedure according to the Manual 4. 全部审核通过后， USP寄发通知函，授予标识使用权和认证证书。USP send out the notification letter to grant Verification Mark&Certificate.2. 签署许可协议Sign the License Agreement 5. USP网站公

7、布通过企业和原料名称The Participants company and ingredient will be posted on USP WebsiteUSP Convention HeadquartersUSP-China 美国药典中华区总部USP-China Laboratory美国药典中华区总部实验室USP-China Laboratory 美国药典中华区总部实验室Total 1000 square meters, equipped with state-of-art analytical instruments Provide technical assistance for c

8、ustomers in China who use USP standards and methodsOffer pharmacopeia training programsPerform USP collaborative testing as part of the reference standard developmentSupport USP Ingredient Verification ProgramThird party laboratory services such as USP-NPA program一期占地面积 1000多平方米, 装备有现代化的实验仪器向中华区使用US

9、P标准和方法的用户提供技术帮助参与标准物质开发流程中的联合检测提供USP药典培训课程为USP原料认证计划提供支持第三方实验室检测服务 (例如USP-NPA检测项目)Professional Education Courses药典培训课程Convenient online and classroom formats.传统面授与网络课堂结合详情请登陆USP官方网站中文版： 2021/9/1310Upcoming USP Pharmacopeia Education Courses and Workshops in ChinaName of Class/Workshop 课程/研讨会名称Date 日

10、期Place 地点Instructor 讲师1USP溶出度高级课程2008年10月27-28中国 上海Erika S. Stippler博士美国药典委员会溶出度专家2有效使用USP标准及USP对法定方法验证和残留溶剂检测的最新要求2008年10月29-30中国 上海蔡松君博士美国药典委员会特聘专家俞炯博士 USP-China实验室总监操洪欣USP-China客户经理3USP通则和相关统计检验的实际应用2008年11月4-5中国 上海JAMES E. De MUTH博士美国药典委员会通则专家委员会（2005-2010）主席4“美国最新食品补充剂、植物产品和功能性食品成分法规及美国药典的作用”研讨

11、会2008年11月11-12中国 广州James Griffiths美国药典委员会食品和食品补充剂标准副总裁5cGMP: 药物活性成分(API)的质量体系管理方式2008年12月09日 中国 上海Keith E. Conerly美国药典委员会质量总监6微生物检测基础2008年12月17-18中国 杭州Radhakrishna Tirumalai美国药典委员会高级科学家China and USP: Partnering Opportunities Memoranda of Understanding官方合作：谅解备忘录 2008年3月3日至5日,国家食品药品监督管理局吴浈副局长应邀率团访问美国药

12、典委员会,签署中美药典合作备忘录。中美两国药典委员会合作备忘录内容标准：为了完善双方各自药典标准，双方同意通过制定相关程序及组织工作人员制定新的药典标准以及修订已有药典标准。相关程序包括：遴选双方感兴趣的标准或通则项目。工作关系：考虑促进工作关系，双方同意每两年在中国或美国举办一届科学大会，根据需要每年召开一次或多次双方高层双边会议。 开展访问学者项目和培训交流项目。 代理美国药典在中国的销售发行。翻译：为便于美国药典在中文使用者中的应用，双方同意开展将美国药典翻译成中文的工作；另外，双方同意USP对中国药典英文版语言校核工作给予必要协助。第三方认证：为了保证良好质量的原料和制剂在中、美两国的

13、使用和达到双方出口要求，双方同意探讨建立适宜的方法对希望将产品进口到中国或出口至美国的原料生产商进行评估、检验和审核。USP Dietary Supplement Verification(DSVP)美国药典食品补充剂认证Look for the USP-Verified Mark on Your Dietary Supplements寻找食品补充剂上的USP认证标志Your assurance 您可以获得以下保证Whats on the label is in the bottle 内容物和标签”表里如一”The supplement does not contain 补充剂不含有达到危害水

14、平的污染物harmful levels of contaminants.The supplement will break 补充剂完全溶解有利于体内吸收 down properly to allow ingredients to dissolve in your body.The supplement has 生产工艺安全,卫生been made under safe, sanitary,manufacturing processes.USP Dietary Supplement - Product Verification美国药典食品补充剂 - 产品认证Products covered by

15、 this program 计划包括以下产品Vitamin supplements 维生素补充剂Mineral supplements 矿物质补充剂Amino Acid supplements 氨基酸补充剂Botanicals 植物类补充剂Non-botanical dietary supplements covered by DSHEA and legally marketed in the U.S. (e.g. fish oil, chondroitin sulfate sodium, glucosamine, etc.) 符合食品补充剂健康教育法并在美国合法上市的非植物类补充剂产品(如鱼

16、油, 硫酸软骨素钠, 葡糖胺等)USP31-NF26 收载 (但不仅限于)Aloe (dried latex of the leaves ) 芦荟 (干燥后的胶体) Capsaicin 辣椒素Capsicum Oleoresin 辣椒油脂Powdered Hawthorn Leaf with Flower 山楂叶/花(粉状)Powdered Licorice (Extract) 甘草(提取物 ) Lutein (preparation) 叶黄素(制品)Lycopene (preparation) 番茄红素 (制品)Garlic (powder, extract, fluidextract, d

17、elayed-Release Tablets) 大蒜 (粉状提取物, 液体提取物, 缓释片)Ginger ( Powder, Capsules, Tincture) 生姜(粉状物, 胶囊,酊剂)Ginkgo 银杏GinSeng (Asian, American) 人参USP Dietary Supplement - Product Verification美国药典食品补充剂 - 产品认证USP Dietary Supplement - Product Verification美国药典食品补充剂 - 产品认证Pharmacopoeia Forum ( PF) 收载 (但不仅限于)Grape Se

18、eds Oligomeric Proanthocyanidins 葡萄籽低聚原花青素 Powdered Soy Isoflavones Extract 大豆异黄酮提取物Powdered Bilberry Extract 越桔提取物 (粉状)Powdered Decaffeinated Green Tea Extract 去咖啡因绿茶提取物(粉状)Pre-Audit Critical Documentation预审中关键文件Document Management 文件管理程序Training培训程序Sample/Material Tracking 样品/物料可追溯性Equipment Calib

19、ration and Preventative Maintenance设备校正和预防性维护Process Performance 工艺运行Change Control 变更控制Label Control 标签控制Laboratory Control 实验室控制Product Stability 产品稳定性Deviations (OOS) 偏差调查Complaint/Recall 投诉/召回Electronic Data Control 电子化数据控制Supplier Verification 供应商确认GMP Audit of Manufacturing Sites生产场地的GMP检查Audi

20、t for compliance with 审核依据The USP General Chapter, “Manufacturing Practices for Dietary Supplements” 美国药典 “食品补充剂生产管理规范”cGMP in Manufacturing, Packaging, Labeling, or Holding operations for Dietary Supplements (21CFR111)美国联邦法规(21CFR111) 食品补充剂良好生产管理规范Manufacturers meeting USP GMPs will easily be able

21、to meet FDA GMPs生产厂家如符合USP的GMP要求可以更容易达到FDA的GMP要求.On-Site Audit and Acceptance Criteria现场审核和接受标准Auditors will review the following mandatory criteria:审核员将会审核下列强制性要求:Organization/Personnel 组织/人员Document Management Systems 文件管理体系Adequate Equipment/Facilities 满足要求的设备/设施Sample/Component Control Program 样

22、品/物料的控制程序Deviation Policy/Logs 偏差方针/记录Appropriate Laboratory Controls 合适的实验室控制Label Control Revision Process 标签修订的控制过程Shelf-Life Evaluation Program 货架期评估Quality Assurance Review/Release 质量保证复核/放行程序Process Performance Evaluation 工艺运行评估Electronic Records/Computerized Systems Compliance 电子化记录/计算机系统的符合性

23、Product Documentation文件审核Manufacturing processes documentation 生产过程文件Master Formula 主配方Environmental controls 环境控制QC check points 质量控制检查点Equipment, reprocessing criteria 设备, 再加工标准Cleaning procedures 清洁程序Quality control documentation, (continued) 质量控制文件Raw material and in-process material specificati

24、ons 原材料和中间物料标准Packaging and labeling material including specifications and samples 包装和标签的采样和质量标准Final product specifications conform to USPNF when applicable, or per acceptable manufacturer criteria 成品符合USP-NF或可接受的生产厂商标准Product Documentation, Continued文件审核Quality Control Documentation 质量控制文件Method v

25、erification (USP General Chapter validation of compendial methods) 方法验证 USP Reference materials (USP RS or acceptable characterization to support suitability of use)标准品(USP RS 或可以接受的标准品)Stability 稳定性Long term (label storage conditions through end of declared shelf-life)长期(直至宣称的货架期为止的储存条件)Accelerated

26、 (1 lot, 3 months at 40C/75%RH)加速(1批, 3个月, 40C/75%RH)Number of products lots evaluated chosen by product categories = n + 1 基于产品类别的评估批数选择 n + 1 Where n = # of products in category 产品类别Minimum of 3 lots 至少三批Laboratory Testing of Product Samples样品的实验室测试Identity 鉴别Potency/label declaration 效价/标签说明Perfo

27、rmance characteristics 特性Contaminantsnot to exceed acceptable levels 污染物不超过可接受水平Heavy metals 重金属Pesticides (botanicals) 农药残留(植物类)PCBs, Dioxins, and Furans (fish oil) 聚氯联苯, 二恶英, 呋喃(鱼油)Microbial contaminants: Total plate count; yeast & molds; pathogens (E. Coli, Salmonella, S. Aureus); aflatoxins (Bot

28、anicals) 微生物污染: 总菌落数, 酵母&霉菌, 致病菌(大肠杆菌, 沙门氏菌, 金黄色葡萄球菌), 黄曲霉素(植物类)Other quality standards (Friability, hardness as appropriate) 其它质量指标(如适用, 脆碎度, 硬度等)Review of Mark Usage 标识使用审核Manufacturers must submit for USPs approval, all artwork for product labels and promotional materials carrying the mark. 生产厂家必

29、须提交带有该标识的产品标签和促销材料原件, 并由USP批准.USP will review mark use for USP会审核标识Appropriate proportions and look 适当的比例和外观Descriptive statement appearing with mark 有关标识的陈述语Clarity and good taste 清晰美观Proper representation of verification 对USP认证的恰当体现Approval Process 批准程序Status of issues or deficiencies 偏差或事件状态Actio

30、n Level 1 issues involve major changes to the current quality system 1级行动水平 包含对目前质量体系的主要变更Action Level 2 issues involve lack of information regarding quality system program element 2级行动水平 缺少质量体系元素相关的信息Action Level 3 issues involve need for clarifying information 3级行动水平 需要澄清说明相关的信息Formal letter notif

31、ies participant of approval of product to carry mark 正式书面通知参与者认证产品被批准使用USP标识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 thatUSP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

32、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 Veri

33、fied 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. an

34、d 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, glucosami

35、ne, 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 U

36、SP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

37、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饮食补充剂成分认证的列举Chondroitin Sulfate Sodium 硫酸软骨素钠Yantai Dongcheng Biochemical Co., Ltd. (China) 烟台东城生化有限公司（中国）TSI Health Sciences (中国

38、）Inter Farma, S.A. (Argentina)（阿根廷）Fish Oil 鱼油Ocean Nutrition CanadaSpirulina Powder 螺旋藻粉Parry Nutraceuticals (India) (印度)Acetyl L-Carnitine Arginate Dihydrochloride 乙酰L肉碱精氨酸二盐酸盐Sigma Tau (Italy) (意大利)Glycine Propionyl L-Carnatine Hydrochloride 氨基乙酸丙酰左旋肉碱盐酸盐Sigma Tau (Italy) (意大利)USP Verified Ingred

39、ients (Cont)通过USP饮食补充剂成分认证的列举(续)B-Carotene B-胡萝卜素Zhejiang Medicine Company / Xinchang Pharmaceutical Factory 浙江医药股份有限公司新昌制药厂 Coenzyme Q10 辅酶Q10Zhejiang Medicine Company / Xinchang Pharmaceutical Factory 浙江医药股份有限公司新昌制药厂Glucosamine Hydrochloride盐酸葡萄糖胺 Yantai Dongcheng Biochemical Co., Ltd. (China) 烟台东

40、城生化有限公司（中国）Summary of USP Verification美国药典认证项目总结SummaryWhy DSVP, IVP总结为何选择DSVP, IVP认证Dietary supplement manufacturers will prefer USP-verified ingredients食品补充剂生产厂家倾向于通过USP认证的原料USP verification of ingredients will enhance consumer confidence in USP-certified supplementsUSP原料认证可进一步增强客户对于通过USP认证的食品补充剂产

41、品的信心Improve the quality of dietary supplements有助于提高食品补充剂产品的质量Help consumers and healthcare professionals assess dietary supplement products有助于顾客和保健行业专业人士识别食品补充剂产品Assure consumers and healthcare professionals of the quality of USP verified dietary supplements确保提供给消费者和保健行业专业人士的经USP认证的食品补充剂的质量SummaryWhy USP总结为何选择美国药典The IVP is backed by USPsLong history and authoritative status in standards settingStandards to support compliancewith DSHEA & FDAs pro