NPA GMP revised chinese version[1].doc

Natural Products Association GMP Standard v3-2008 Page 73 of 73 Natural Products Association Good Manufacturing Practices(GMP) Standard for Dietary Supplements NPA 膳食补充剂GMP 标准 The Natural Products AssociationThe Natural Products Association was founded in 1936 to promote and protect the unique values and shared interests of retailers and suppliers of natural nutritional foods and natural products. The Natural Products Association is a non-profit 501(c)(6) association whose mission is to unite a diverse membership, from the smallest health food store to the largest natural products supplier. We champion consumers freedom of choice in our marketplace. We strengthen and safeguard retailers and suppliers. We build strong markets to fuel industry growth. We act together with uncompromising integrity, and we encourage all to reach ever higher standards of quality. We are the largest trade association in the Natural Products industry by numbers, representing over 10,000 members.关于NPA天然产品协会（NPA）是为了促进和保护天然营养食品与天然产品的供应商与零售商的行业价值观与利益，于1936年成立的。NPA是个非盈利的协会，它的使命就是联合不同的会员，从最小的健康食品店到最大的天然产品供应商。我们捍卫消费者的自由选择权。我们也加强并保护零售商与供应商。我们为促进工业的增长构建强大的市场。我们共同坚持诚信，我们鼓励所有成员的产品达到更高标准的质量。在天然产品方面我们是最大的贸易协会（会员超过10000个）。BackgroundThe Natural Products Association has always taken a leadership role in promoting quality standards and has developed proactive, self-regulatory programs for that purpose. The Association was the first organization to offer a third-party GMP certification program specific to the manufacturing of dietary supplements and dietary ingredients. The Natural Products Association established Association GMP standards for dietary supplements in 1999 and updated the standard in 2000. At time of publication, these GMP standards represented industrys best practices served as the basis of the NPA GMP Certification Program as well as establishing a higher level of control than was currently required by FDA. 背景NPA在提高质量标准发展方面一直是起着领导作用，并为此发展了前瞻性的自我监管。本协会是第一个专门为膳食补充剂与膳食原料生产厂提供第三方GMP认证的组织。NPA在1999年建立了协会的膳食补充剂GMP标准，并且在2000年进行了更新。在其出版时，NPA的GMP规程以行业的最高标准为基础，同时建立比FDA的当时要求更高水平的控制。In June 2007, the FDA published the final GMP regulation specific to dietary supplements (21 CFR 111). In order to keep the NPA GMP Certification program relevant and reflect the highest level of industry good manufacturing practices, the NPA GMP Standard has been revised to include all of the FDA GMP requirements of 21 CFR Part 111 and certain requirements from the 2000 version of the NPA GMP standard that exceed requirements of the FDA GMPs, or reflect best industry practices, and/or are necessary for the evaluation of compliance to the NPA GMP standard.2007年6月FDA公布最新的膳食补充剂GMP质量管理规范（联邦法规第21篇，第111款）。为了保证NPA GMP能反映最高水平的行业性生产质量管理实践，NPA的GMP标准进行了修订，包括了FDA 联邦法规第21篇，第111款中的所有要求以及2000版NPA GMP标准中的部分超过FDA要求的条款或者反映行业最佳实践的条款，或者是那些对于NPA GMP符合评估必须的条款。PurposeThe Natural Products Association GMP Standard serves as the basis for the Associations GMP Certification Program. All program requirements and support materials relate to the NPA GMP standard. The NPA GMP standard is a living document and will be reviewed and potentially updated to reflect current best practices, advances in technology, and ingredient and product knowledge.目的NPA GMP标准服务于协会的GMP认证规程。所有规程的要求和支持性资料都要与NPA GMP的标准相关。NPA GMP标准是一个动态的文件，会为了反映目前最好的实践、先进的技术，和原料、产品知识而被审核并可能更新。ScopeThe NPA GMP standard established good manufacturing practices requirements for and dietarysupplement manufacturers, dietary ingredient manufacturers, and distributors that want to be certified through the Natural Product Associations GMP Certification Program. All companies, including dietary ingredient suppliers, that are seeking certification through the NPA GMP certification program will be required to meet the NPA GMP standard in all areas that are applicable to the manufacturers, distributors, or suppliers operations.范围NPA GMP标准是为了想通过NPA GMP认证的膳食补充剂生产商、膳食成分生产商和经销商建立的良好生产质量管理规范。所有试图通过NPA GMP认证的公司（也包括膳食原料供应商），必须在生产、分销、零售等领域符合NPA GMP标准。Table of Contents 目录Subpart A: General Provisions111.1 Who is subject to this part?NPA.A.1 Who is Subject to the NPA GMP Standard?111.3 What definitions apply to this part?NPA.A.1 Definitions111.5 Do other statutory provisions and regulations apply?NPA.A.2 Other Statutory Provisions and Regulations部分A：总则111.1谁是该条款监管对象？NPA.A.1谁必须符合NPAGMP标准？111.3 适用于这部分的定义是什么？NPA.A.1定义111.5 其他法定条款和法规可以应用吗？NPA.A.2其他法规和规程Subpart B: Personnel111.8 What are the requirements under this subpart B for written procedures?111.10 What requirements apply for preventing microbial contamination from sick orinfected personnel and for hygienic practices?111.12 What personnel qualification requirements apply?NPA.B.1 Personnel Qualifications111.13 What supervisor requirements apply?111.14 Under this subpart B, what records must you make and keep?部分B：人员要求111.8 对B部分的书面要求是什么？111.10 为了预防因疾病、创伤和人员的卫生习惯而造成的微生物污染的要求是什么？111.12人员资质的要求是什么？NPA.B.1 人员要求111.13 对管理人员的要求是什么？111.14 在B部分，必须填写与保存的记录是什么？Subpart C: Physical Plant and Grounds111.15 What sanitation requirements apply to your physical plant and grounds?NPA.C.1 Pest ControlNPA.C.2 Water Supply111.16 What are the requirements under this subpart C for written procedures?NPA.C.3 Documentation Requirements for Plant Grounds111.20 What design and construction requirements apply to your physical plant?111.23 Under this subpart C, what records must you make and keep?NPA.C.4 Record Requirements for Processing Rooms/Areas部分C：厂房和地面的要求111.15 对于厂房和地面的卫生要求是什么？NPA.C.1 害虫的控制NPA.C.2 供水111.16 在C部分中书面规程的要求是什么？NPA.C.3 厂房地面的文件要求111.20 厂房的设计与建造要求是什么？111.23 在C部分，必须填写与保存的记录是什么？NPA.C.4加工厂房/区域的记录要求Subpart D: Equipment and Utensils111.25 What are the requirements under this subpart D for written procedures?111.27 What requirements apply to the equipment and utensils that you use?111.30 What requirements apply to automated, mechanical, or electronic equipment?111.35 Under this subpart D, what records must you make and keep?NPA.D.1 Records for Equipment and Utensils部分D：设备与器具111.25 在D部分中书面规程的要求是什么？111.27使用的设备与器具的要求是什么？111.30 自动的、机械的、电子的设备的要求是什么？111.35 在D部分，必须填写和保存的记录是什么？NPA.D.1 设备和器具的记录Subpart E: Requirement to Establish a Production and Process Control System111.55 What are the requirements to implement a production and process control system?111.60 What are the design requirements for the production and process control system?111.65 What are the requirements for quality control operations?111.70 What specifications must you establish?NPA.E.1 SpecificationsNPA.E.2 Establishing Expiration or Product Shelf-Life Dates111.73 What is your responsibility for determining whether established specifications are met?111.75 What must you do to determine whether specifications are met?NPA.E.3 Confirming Identity Specifications111.77 What must you do if established specifications are not met?111.80 What representative samples must you collect?111.83 What are the requirements for reserve samples?NPA.E.4 Reserve Samples111.87 Who conducts a material review and makes a disposition decision?111.90 What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with 111.70 is not met?111.95 Under this subpart E, what records must you make and keep?部分E：建立一个生产和过程控制系统的要求111.55实施一个生产和过程控制系统的要求是什么？111.60 生产和过程控制的设计要求是什么？111.65 质量控制操作的要求是什么？111.70 必须建立的质量标准是什么？NPA.E.1 质量标准NPA.E.2 产品有效期和货架期的建立111.73确定是否符合已建立的质量标准的责任是什么？111.75 为了确定是否符合质量标准必须做什么？ NPA.E.3 确定鉴别的质量标准111.77 如果产品不符合质量标准必须做什么？111.80必须收集什么代表性的样品？111.83 留样的要求是什么？NPA.E.4 留样111.87 谁作物料的审核并作处理的决定？ 111.90当有偏差或不曾预料的事件发生或不符合按 111.70建立的质量标准时，处理、过程中调整和返工的要求是什么？111.95在E部分，必须填写与保存的记录是什么？Subpart F: Production and Process Control System: Requirements for Quality Control111.103 What are the requirements under this subpart F for written procedures?111.105 What must quality control personnel do?111.110 What quality control operations are required for laboratory operations associated with theproduction and process control system?111.113 What quality control operations are required for a material review and disposition decision?111.117 What quality control operations are required for equipment, instruments, and controls?111.120 What quality control operations are required for components, packaging, and labels beforeuse in the manufacture of a dietary supplement?111.123 What quality control operations are required for the master manufacturing record, the batchproduction record, and manufacturing operations?111.127 What quality control operations are required for packaging and labeling operations?111.130 What quality control operations are required for returned dietary supplements?111.135 What quality control operations are required for product complaints?111.140 Under this subpart F, what records must you make and keep?部分F：生产和过程控制系统：质量控制的要求111.103 F部分要求的书面规程是什么？111.105 质量控制人员必须做什么？111.110 对生产和过程控制相关的实验室操作的质量控制要求是什么？111.113 对于物料审核及其处理决定的质量控制要求是什么？111.117 对于设备、仪器及控制的质量控制要求是什么？111.120 组分、包装、标签在膳食补充剂生产使用前的质量控制要求是什么？111.123 生产工艺、批生产记录和生产操作的质量控制要求是什么？111.127包装、贴标签操作的质量控制要求是什么？111.130退回的膳食补充剂的质量控制要求是什么？111.135产品的投诉的质量控制要求是什么？111.140在F部分，必须添写与保存的记录是什么？Subpart G: Production and Process Control System: Requirements for Components, Packaging, andLabels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement111.153 What are the requirements under this subpart G for written procedures?111.155 What requirements apply to components of dietary supplements?NPA.G.1 Components111.160 What requirements apply to packaging and labels received?111.165 What requirements apply to a product received for packaging or labeling as a dietary supplement(and for distribution rather than for return to the supplier)?NPA.G.2 Products Received for Packaging or Labeling as a Dietary Supplement111.170 What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?111.180 Under this subpart G, what records must you make and keep?部分G：生产和过程控制系统：对于组分、包装和标签的要求和收到的用于包装或贴签的膳食补充剂产品的要求111.153 G部分要求的书面规程是什么？111.155 膳食补充剂对于组分的要求是什么？NPA.G.1 组分111.160已接收的包装、标签的要求是什么？111.165 已接收的用于膳食补充剂包装或贴标签的产品（为了销售的）要求是什么？ NPA.G.2 已接收的用于膳食补充剂包装或贴标签的产品111.170 对于不合格的组分、包装、标签的要求，和已经包装和贴标签的不合格的成品有什么要求？111.180在G部分，必须添写和保存的记录是什么？Subpart H: Production and Process Control System: Requirements for the MasterManufacturing Record111.205 What is the requirement to establish a master manufacturing record?NPA.H.1Requirements Master Manufacturing Records111.210 What must the master manufacturing record include?部分H：生产和过程控制系统：生产工艺的要求111.205 建立生产工艺的要求是什么？NPA.H.1 生产工艺的要求111.210 生产工艺必须包括什么？Subpart I: Production and Process Control System: Requirements for the BatchProduction Record111.255 What is the requirement to establish a batch production record?NPA.I.1 Requirements for the Issuance of Batch Production Records111.260 What must the batch record include?部分I：生产和过程控制系统：批生产记录的要求111.255 批生产记录的要求是什么？NPA.I.1 批生产记录的签发要求111.260 批生产记录必须包括什么？Subpart JProduction and Process Control System: Requirements for Laboratory Operations111.303 What are the requirements under this subpart J for written procedures?111.310 What are the requirements for the laboratory facilities that you use?111.315 What are the requirements for laboratory control processes?111.320 What requirements apply to laboratory methods for testing and examination?111.325 Under this subpart J, what records must you make and keep?部分J：生产和控制系统：实验室操作的要求111.303 J部分要求的书面规程是什么？111.310实验室的设施要求是什么？111.315 实验室控制规程要求是什么？111.320 实验室检测方法和检查的应用要求是什么？111.135 J部分必须填写与保存的记录是什么？Subpart KProduction and Process Control System: Requirements for Manufacturing Operations111.353 What are the requirements under this subpart K for written procedures?111.355 What are the design requirements for manufacturing operations?111.360 What are the requirements for sanitation?111.365 What precautions must you take to prevent contamination?111.370 What requirements apply to rejected dietary supplements?111.375 Under this subpart K, what records must you make and keep?部分K：生产和控制系统：对于生产操作的要求111.353 K部分要求的书面规程是什么？111.355 生产操作的设计要求是什么？111.360 消毒的要求是什么？111.365预防污染采取的必要措施是什么？111.370 不合格膳食补充剂的要求是什么？111.375 K部分必须添写与保存的记录是什么？Subpart LProduction and Process Control System: Requirements for Packaging and LabelingOperations111.403 What are the requirements under this subpart L for written procedures?111.410 What requirements apply to packaging and labels?111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations?NPA.L.1 Lot or Batch Numbers on Products111.420 What requirements apply to repackaging and relabeling?111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected fordistribution?111.430 Under this subpart L, what records must you make and keep?部分L：生产和过程控制系统：包装与贴标签操作的要求111.403 L部分要求的书面规程是什么？111.410 对于包装和标签的要求是什么？111.415 对于灌装、装配、包装、贴签及相关操作的要求是什么？NPA.L.1 产品的批号111.420 重新包装与重新贴签的要求是什么？111.425 不合格的已包装、标签的膳食补充剂的要求什么？ 111.430 L部分必须填写与保存的记录是什么？Subpart MHolding and Distributing111.453 What are the requirements under this subpart M for written procedures?111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?111.460 What requirements apply to holding in-process material?111.465 What requirements apply to holding reserve samples of dietary supplements?111.470 What requirements apply to distributing dietary supplements?111.475 Under this subpart M, what records must you make and keep?NPA.M.1 Recall Procedures部分M：贮存与销售111.453 M部分要求的书面规程是什么？111.455 贮存组分、膳食补充剂、包装和标签的要求是什么？111.460 贮存过程中物料的要求是什么？111.465贮存膳食补充剂留样的要求是什么？111.470 膳食补充剂销售的要求是什么？111.475 M部分必须填写与保存的记录是什么？NPA.M.1 召回规程Subpart NReturned Dietary Supplements111.503 What are the requirements under this subpart N for written procedures?111.510 What requirements apply when a returned dietary supplement is received?111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?111.520 When may a returned dietary supplement be salvaged?111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?111.530 When must an investigation be conducted of your manufacturing processes and other batches?111.535 Under this subpart N, what records must you make and keep?部分N：退回的膳食补充剂产品111.503 N部分要求的书面规程是什么？111.510收到退回的膳食补充剂产品的处理要求是什么？111.515 什么情况下退回的膳食补充剂必须被销毁，或者适合的方式处理？111.520 什么情况下退回的膳食补充剂可以回收？111.525 被退回的膳食补充剂，质量控制人员同意返工的要求是什么？111.530 什么情况下必须实施对该批的生产过程和其他批次的调查？111.535 N部分必须填写与保存的记录是什么？Subpart OProduct Complaints111.553 What are the requirements under this subpart O for written procedures?111.560 What requirements apply to the review and investigation of a product complaint?111.570 Under this subpart O, what records must you make and keep?部分O：产品投诉111.553 O部分要求的书面规程是什么？111.560 对于产品投诉进行审核与调查的要求？111.570 O部分必须填写与保存的记录是什么？Subpart PRecords and Recordkeeping111.605 What requirements apply to the records that you make and keep?111.610 What records must be made available to FDA?部分P：记录与记录的保存111.605 对于要填写与保存记录的要求是什么？111.610 对于FDA必须要什么记录？Subpart A: General Provisions部分A：总则 111.1 Who is subject to this part (21 CFR 111)?111.1谁是该条款监管对象？（21 CFR 111）？ (a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including: (a)除非段落（b）另有章节说明，如果您生产、包装、贴签或贮存膳食补充剂就需符合该条款，包括：(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and(1) 生产膳食补充剂，但是由另一个厂家包装贴签的企业。(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.(2) 进口的膳食补充剂或者为美国各州、地区、哥伦比亚或波多黎各地区提供进口的企业。 (b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.(b) 如果这些膳食补充剂在零售企业储存的唯一目的是直接零售给个人消费者，则无需符合关于存储膳食补充剂的要求，零售企业不包括单个零售商的仓库或直接销售给个人消费者的其他存储设施。NPA Supplement: Subpart AGeneral ProvisionsNPA补充：部分A总则NPA.A.1 Who is Subject to the NPA GMP Standard? ( 111.1)NPA.A.1 谁必须符合NPAGMP标准（111.1）A.1.1 You are subject to the NPA GMP Standard and must demonstrate compliance to the NPA GMPStandard through third-party audits if you manufacture, package, label or hold dietary supplements and/or dietary ingredients and want to be certified under the Natural Products Association GMP Certification Program.A.1.1 如果生产、包装、贴签或者贮存膳食补充剂或其原料并且希望通过NPA GMP的认证，就必须符合GMP标准，并且通过第三方进行NPA GMP审计。 111.3 What definitions apply to this part?111.3 这部分的定义The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. For the purpose of this part, the following definitions also apply:定义和解释可参考联邦食品、药品、化妆品法案201部分，具体解释如下：Actual yield means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular dietary supplement.实际产量 指某种膳食补充剂在生产、包装的任一适当的阶段实际生产出的数量。Batch means a specific quantity of a dietary supplement that