(iv) Designed and constructed to withstand the environment in which they are used, the action of components or dietary supplements, and, if applicable, cleaning compounds and sanitizing agents; and （四）设计及建造 ， 经受住它们使用的组件或膳食补充剂的行动，如果适用，清洁剂和消毒剂环境;
(v) Maintained to protect components and dietary supplements from being contaminated by any source. （五）维护 ， 保护元件和膳食补充剂被污染的任何源。
(4) Equipment and utensils you use must have seams that are smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants. （4）设备和器具必须为您使用的是顺利保税或维护以尽量减少灰尘，污物，有机物质积累接缝，粒子的组成部分或膳食补充剂，或任何其他无关的材料或污染物。
(5) Each freezer, refrigerator, and other cold storage compartment you use to hold components or dietary supplements: （5）每个冰柜，冰箱，冷藏及其他车厢使用持有组件或膳食补充剂：
(i) Must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that indicates and records, or allows for recording by hand, the temperature accurately within the compartment; and （一）必须装有一个指示温度计，温度测量装置，或温度记录装置 ， 指示和记录，或记录允许的手，在车厢内精确的温度;及
(ii) Must have an automated device for regulating temperature or an automated alarm system to indicate a significant temperature change in a manual operation. （二）必须有调节温度或自动报警系统显示在一个手动操作温度变化显着的自动化设备。
(6) Instruments or controls used in the manufacturing, packaging, labeling, or holding of a dietary supplement, and instruments or controls that you use to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), water activity, or other conditions, to control or prevent the growth of microorganisms or other contamination must be: （6）文书或控制的制造，包装，标志，或膳食补充剂持有使用，文书或控制 ， 用于测量，调节，或记录温度，氢离子浓度（pH值），水的活动，或，其他条件以控制或防止微生物或其他污染物的增长必须是：
(i) Accurate and precise; （一）准确和精确;
(ii) Adequately maintained; and （二）充分维护;及
(iii) Adequate in number for their designated uses. （三）适当在其指定的使用次数。
(7) Compressed air or other gases you introduce mechanically into or onto a component, dietary supplement, or contact surface or that you use to clean any contact surface must be treated in such a way that the component, dietary supplement, or contact surface is not contaminated. （7）压缩空气或其他气体你介绍机械进入或到一个组成部分，膳食补充剂，或接触面 ， 或者使用清洁任何接触表面必须处理的方式 ， 组件，膳食补充剂，或接触面不受污染。
(b) You must calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement. （b）你必须校准设备和控制您在生产或测试组件或膳食补充剂的使用。 You must calibrate: 你必须调整：
(1) Before first use; and （1）在首次使用;及
(2) At the frequency specified in writing by the manufacturer of the instrument and control; or （2在频率）指定由该文书的书写和控制制造商;或
(3) At routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument and control. （3）在例行的间隔或其他必要措施 ， 确保准确性和文书和控制精度。
(c) You must repair or replace instruments or controls that cannot be adjusted to agree with the reference standard. （三）您必须维修或更换工具或无法进行调整 ， 以同意参考标准控制。
(d) You must maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplements. （d）您必须保持，清洁和消毒，必要时，所有设备，用具，以及任何其他接触面用于制造，包装，标签，或持有部件或膳食补充剂。
(1) Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning, and sanitizing. （1）设备和用具外 ， 必须采取必要进行彻底的维修，清洁和消毒。
(2) You must ensure that all contact surfaces, used for manufacturing or holding low-moisture components or dietary supplements, are in a dry and sanitary condition when in use. （2）你必须确保所有接触的表面，制造或持有低水分组件或膳食补充剂使用的，是在干燥 ， 卫生情况时使用。 When the surfaces are wet-cleaned, they must be sanitized, when necessary, and thoroughly dried before subsequent use. 当表面的湿清洗，他们必须消毒，必要时 ， 再彻底干燥后使用。
(3) If you use wet processing during manufacturing, you must clean and sanitize all contact surfaces, as necessary, to protect against the introduction of microorganisms into components or dietary supplements. （3）如果您在生产过程中使用的湿处理，你必须清洁和消毒一切必要接触的表面，防止微生物的成组件或膳食补充剂介绍。 When cleaning and sanitizing is necessary, you must clean and sanitize all contact surfaces before use and after any interruption during which the contact surface may have become contaminated. If you use contact surfaces in a continuous production operation or in consecutive operations involving different batches of the same dietary supplement, you must adequately clean and sanitize the contact surfaces, as necessary. 当清洁和消毒是必要的，你必须清洁和消毒 ， 接触面都在使用之前和之后 ， 在此期间 ， 接触面可能已被污染的中断。如果您使用的接触面在一个连续的生产经营 ， 或在涉及不同批次的连续行动同样的营养补充剂，你必须充分清洁和消毒的接触面，必要的。
(4) You must clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements. （4）您必须清洁的表面不与组件或按必要的频率 ， 以防止污染成分或膳食补充剂膳食补充剂的直接接触。
(5) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) must be: （5）单服务的物品（如一次性使用，纸杯，纸毛巾）必须准备用具：
(i) Stored in appropriate containers; and （i）在适当的容器内;及
(ii) Handled, dispensed, used, and disposed of in a manner that protects against contamination of components, dietary supplements, or any contact surface. （二）处理，在配发，使用和处置的方式 ， 对部分污染保护的，膳食补充剂，或任何接触面。 (6) Cleaning compounds and sanitizing agents must be adequate for their intended use and safe under their conditions of use; （6）清洁剂和消毒剂必须有足够其用途 ， 并根据使用条件的安全;
(7) You must store cleaned and sanitized portable equipment and utensils that have contact surfaces in a location and manner that protects them from contamination. （7）你必须存储清洗和消毒便携式设备和器具表面接触的地点和方式 ， 保护他们免受污染。
[72 FR 34942, June 25, 2007, as amended at 73 FR 13124, Mar. 12, 2008] [72阻燃34942，2007年6月25日，截至73阻燃13124，2008年3月12日修订]
Sec. 秒。 111.30 What requirements apply to automated, mechanical, or electronic equipment? 111.30什么要求适用于自动化，机械或电子设备？
For any automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, you must: 对于任何自动化，机械或电子设备 ， 用于制造，包装，标签，或持有饮食的补充，你必须：
(a) Design or select equipment to ensure that dietary supplement specifications are consistently met; （一）设计或选择装备 ， 以确保膳食补充剂规格始终满足;
(b) Determine the suitability of the equipment by ensuring that your equipment is capable of operating satisfactorily within the operating limits required by the process; （二）确定 ， 确保你的设备是内运作的经营能力的限制令人满意的过程所需的设备是否合适;
(c) Routinely calibrate, inspect, or check the equipment to ensure proper performance. （三）经常校准，检查，或检查设备 ， 以确保适当的表现。 Your quality control personnel must periodically review these calibrations, inspections, or checks; 您的质量控制人员必须定期检讨这些校准，检查，或检查;
(d) Establish and use appropriate controls for automated, mechanical, and electronic equipment (including software for a computer controlled process) to ensure that any changes to the manufacturing, packaging, labeling, holding, or other
operations are approved by quality control personnel and instituted only by authorized personnel; and （四）建立和使用自动化，机械和电子设备（包括计算机控制的过程适当的控制软件），以确保任何制造，包装的变化，贴标，控股或其他操作人员的质量控制和批准提起只有经授权的人员;
(e) Establish and use appropriate controls to ensure that the equipment functions in accordance with its intended use. （五）建立和使用适当的管制 ， 以确保按照其用途设备的功能。 These controls must be approved by quality control personnel. 这些控制必须经质量管理人员。
Sec. 秒。 111.35 Under this subpart D, what records must you make and keep? 在这个子部分?111.35，什么记录必须保持你的？
(a) You must make and keep records required under this subpart D in accordance with subpart P of this part. （1）你必须保持必要的按照本附D与本部分附P记录。
(b) You must make and keep the following records: （b）你必须制作并保存以下记录：
(1) Written procedures for fulfilling the requirements of this subpart, including written procedures for: （1）书面程序履行本子部分，包括书面的程序要求：
(i) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement; （一）校准仪器和控制您在生产或测试组件或膳食补充剂的使用;
(ii) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and （二）校准，检测，检查和自动化，机械和电子设备;
(iii) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements; （三）维护，清洁和消毒，必要时，所有的设备，用具，以及其他任何接触面 ， 用于制造，包装，标签，或持有部件或膳食补充剂;
(2) Documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, unless such documentation is kept with the batch record; （2）文档，个别设备的日志，对使用，维护清洁，日期和消毒设备，除非这些文件是与批记录在案;
(3) Documentation of any calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement. In your documentation, you must: （3）任何校准文件，每次进行校准仪器和控制您在生产或测试组件或膳食补充剂的使用。在你的文档，你必须：
(i) Identify the instrument or control calibrated; （一）确定或控制仪器校准;
(ii) Provide the date of calibration; （二）提供的校准日期;
(iii) Identify the reference standard used including the certification of accuracy of the known reference standard and a history of recertification of accuracy; （三）确定的参考标准 ， 用于包括已知的参考标准 ， 认证和准确的重新认证历史的准确性;
(iv) Identify the calibration method used, including appropriate limits for accuracy and precision of instruments and controls when calibrating; （四）确定校准使用的方法，包括准确性和校准仪器和控制精度时 ， 适当限制;
(v) Provide the calibration reading or readings found; （五）提供阅读或校准读数找到;
(vi) Identify the recalibration method used, and reading or readings found, if accuracy or precision or both accuracy and precision limits for instruments and controls were not met; and （六）确定校准方法中使用，并阅读或读数发现，如果准确性或精度或两者准确性和文书和控制精度的限制没有得到满足;及
(vii) Include the initials of the person who performed the calibration and any recalibration. （七）包括人谁执行的校准和任何校准的缩写。
(4) Written records of calibrations, inspections, and checks of automated, mechanical, and electronic equipment; （4）有书面记录的校准，检查和自动化，机械和电子设备的检查;
(5) Backup file(s) of current software programs (and of outdated software that is necessary to retrieve records that you are required to keep in accordance with subpart P of this part, when current software is not able to retrieve such records) and of data entered into computer systems that you
use to manufacture, package, label, or hold dietary supplements. （5）备份文件（章目前的软件程序）（和过时的软件 ， 是必要的检索 ， 您必须按照跟上这一部分，目前的软件时 ， 不能检索这些记录附P记录）数据输入到计算机系统 ， 用于制造，包装，标签，或持有膳食补充剂。
(i) Your backup file (eg, a hard copy of data you have entered, diskettes, tapes, microfilm, or compact disks) must be an exact and complete record of the data you entered. （一）您的备份文件（例如，你已经进入，软盘，磁带，缩微胶片，光盘数据或硬拷贝）必须是输入的数据准确 ， 完整记录。
(ii) You must keep your backup software programs and data secure from alterations, inadvertent erasures, or loss; and （ii）您必须让您的备份软件程序和数据安全的改建，无心创作意图，或损失;及
(6) Documentation of the controls that you use to ensure that equipment functions in accordance with its intended use. （6）控制 ， 您使用 ， 以确保文件 ， 根据设备的功能与用途。
Subpart E--Requirement to Establish a Production and Process Control System 子部分专-要求建立一个生产和过程控制系统
Sec. 秒。 111.55 What are the requirements to implement a production and process control system? 111.55有什么要求实施生产过程控制系统？
You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. 你必须实施生产过程控制 ， 涵盖了制造，包装，标签的所有阶段的系统，以及饮食补充剂举行 ， 以确保膳食补充剂的质量 ， 而且膳食补充剂的包装和作为主制造指定标记记录。
Sec. 秒。 111.60 What are the design requirements for the production and process control system? 111.60什么是为生产和过程控制系统的设计要求是什么？
(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and （1）您的生产和过程控制系统的设计必须确保膳食补充剂的生产，包装，标签，和方式 ， 以确保膳食补充剂的质量 ， 而且膳食补充剂的包装和标签举行所规定的主生产记录;和
(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel. （二）生产和过程控制系统必须包括通过这个L部分的子部分的所有位置的要求 ， 必须审查和质量控制人员批准。
Sec. 秒。 111.65 What are the requirements for quality control operations? 111.65什么是质量控制操作要求？
You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. 你必须落实到制造，包装标识，质量控制操作，并持有生产的食品补充 ， 以确保膳食补充剂的质量经营 ， 而且膳食补充剂的包装和在主生产记录中指定的标记。
Sec. 秒。 111.70 What specifications must you establish? 111.70什么你必须建立规范？
(a) You must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. （a）你必须建立一个对任何点，步骤，或在生产过程中的阶段规范 ， 控
制是必要的 ， 以确保膳食补充剂的质量 ， 而且膳食补充剂的包装和在主生产记录中指定的标记。
(b) For each component that you use in the manufacture of a dietary supplement, you must establish component specifications as follows: （二）对于每个组件 ， 您在一个膳食补充剂生产使用，您必须建立组件的规格如下：
(1) You must establish an identity specification; （1）你必须建立一个标识规范;
(2) You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and （2）你必须建立规范的组件是必要的 ， 以确保纯度，强度和膳食补充剂成分规格制造采用的是组合得到满足;及
(3) You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement. （3）你必须建立对污染的可能掺假或可能导致对膳食补充剂完成一批掺假 ， 以确保膳食补充剂的质量这些类型的限制。
(c) For the in-process production: （三）对于在进程内生产的：
(1) You must establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; （1）你必须建立任何点，步骤，或在主生产记录阶段控制是必要的 ， 以帮助确保符合规格要求的身份，纯度，强度和膳食补充剂的成分，并在过程规范必要时，提供有关污染的可能掺假或可能导致对膳食补充剂完成一批掺假这些类型的限制;
(2) You must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and （2）你必须提供满足为什么在进程规格的基础上适当的文件，会议内容与规范相结合，将有助于确保符合规格要求的身份，纯度，强度，以及膳食补充剂成分和污染就可能掺假或可能导致对膳食补充剂完成一批掺假这些类型的限制;和
(3) Quality control personnel must review and approve the documentation that you provide under paragraph (c)(2) of this section. （3）质量控制人员必须审查和批准的文件 ， 你根据第（三）（2提供）本条。
(d) You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement. （四）必须建立膳食补充剂标签（标签规范）和包装可能会在（包装规格）膳食补充剂接触的规格。包装 ， 可能与膳食补充剂接触必须是安全和合适的用途和不能反应或吸收或其他影响安全或膳食补充剂的质量。
(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement. （五）对于每个膳食补充 ， 你生产 ， 必须建立身份，纯度，强度产品规格，以及对膳食补充剂完成一批组成，并就污染可能掺假，或可能导致这些类型的限制以掺假的，对膳食补充剂完成一批确保膳食补充剂的质量。
(f) If you receive a product from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order. （f）如果您收到一个包装供应商的产品或作为膳食补充剂标签（和分配 ， 而不是返回到供应商），你必须建立规范 ， 提供足够的保证 ， 您收到的产品有足够的识别 ， 是符合您的订单。
(g) You must establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label. （七）必须建立的包装规格和成品包装和标记膳食补充剂，包括规格 ， 确保您使用指定的包装 ， 标签和应用 ， 你指定标签。
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