美国良好操作规范(4)

Sec. 秒。 111.73 What is your responsibility for determining whether established specifications are met? 111.73什么是你的决定是否符合既定规范的责任？

You must determine whether the specifications you establish under 111.70 are met. 您必须确定您是否规范建立在111.70得到满足。

Sec. 秒。 111.75 What must you do to determine whether specifications are met? 111.75你做什么 ， 必须确定是否符合规格要求？

(a) Before you use a component, you must: （一）在您使用的组件，您必须：

(1)(i) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing; （1）（一）进行至少有一个适当的测验或考试 ， 以验证任何组件 ， 是膳食成分标识，除非你呈请根据本条第（一）（1）（ii）该机构和该机构豁免你从这些测试;

(ii) You may submit a petition, under 21 CFR 10.30, to request an exemption from the testing requirements in paragraph (a)(1)(i) of this section. （ii）您可以提交一份请愿书，21岁以下的病死率10.30，要求从本款第（一）（1）（i）该测试要求豁免。 The petition must set forth the scientific rationale, and must be accompanied by the supporting data and information, for proposed alternative testing that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use when the dietary ingredient is obtained from one or more suppliers identified in the petition. 请愿书必须阐明科学原理，并必须由支持数据和资料的陪同下，对拟议其他测试 ， 以证明有没有保证材料的减少，而由百分之百的身份测试提供了保证的身份，膳食成分的使用前当膳食成分是从在请愿书中的一个或多个供应商。 If FDA grants the petition, you must conduct the tests and examinations for the dietary ingredient, otherwise required under 111.75(a)(1)(i), under the terms specified by FDA when the petition is granted; and 如果FDA授予的请愿书，你必须进行测试和膳食成分的考试，否则要求下111.75（1）（1）（i）根据美国FDA规定的条件，当请愿案获准;及

(2) Confirm the identity of other components and determine whether other applicable component specifications established in accordance with 111.70(b) are met. （2）确认身份的其他组成部分 ， 并确定是否其他适用的组件的规格建立了111.70按照（b）得到满足。 To do so, you must either: 为此，你必须：

(i) Conduct appropriate tests or examinations; or （一）进行适当的测试或考试;或

(ii) Rely on a certificate of analysis from the supplier of the component that you receive, provided that: （二）关于证书的分析依靠的元件供应商 ， 您会收到，但条件是：

(A) You first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations; （a）你先资格 ， 通过建立对供应商的测试或检验结果确认 ， 供应商的证书的可靠性分析的供应商;

(B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; （乙）的分析证书 ， 包括对测试或检验方法的说明（仛）使用，测试或考试的限制，以及测试或考试的实际效果;

(C) You maintain documentation of how you qualified the supplier; （c）你是如何保持你的文档合格的供应商;

(D) You periodically re-confirm the supplier's certificate of analysis; and （d）你定期重新确认供应商的分析证书;

(E) Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier. （e）你的质量管理人员审查和批准文件 ， 阐述了合格的基础上（和重新获得资格的任何供应商）。

(b) You must monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement to: （b）您必须监测过程点，步骤或阶段 ， 在管制是必要的 ， 以确保饮食中补充一批成品质量：

(1) Determine whether the in-process specifications are met; and （1）确定是否在进程符合规格要求;及

(2) Detect any deviation or unanticipated occurrence that may result in a failure to meet specifications. （2）发现任何偏离或意料之外的事件 ， 可能导致不符合规范。

(c) For a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, 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. （三）完成的一个子集饮食补充批 ， 你通过一个健全的统计抽样计划确定（或每一批成品），您必须确认您的膳食补充剂完成一批符合身份，纯度，强度，结构产品规格，并就污染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。 To do so: 这样做：

(1) You must select one or more established specifications for identity, purity, strength, composition, and the limits on those types of contamination that may adulterate or that may lead to adulteration of the dietary supplement that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications (or only those product specifications not otherwise exempted from this provision by quality control personnel under paragraph (d) of this section); （1）您必须选择一个或多个身份，纯度，强度，建立规范的组成，以及对污染的可能掺假或可能导致对膳食补充剂掺假这些类型的限制，如果测试或成品检验膳食补充剂的批次，将核查的生产和过程控制系统 ， 其产生的膳食补充剂 ， 以满足所有的产品（或只有那些没有其他产品规格从这一质量管理人员提供豁免规格段（四本节）） ;

(2) You must conduct appropriate tests or examinations to determine compliance with the specifications selected in paragraph (c)(1) of this section; （2）您必须进行适当的检查或检验 ， 以确定在第（c）（1选择了符合规格）本条;

(3) You must provide adequate documentation of your basis for determining that compliance with the specification(s) selected under paragraph (c)(1) of this section, through the use of appropriate tests or examinations conducted under paragraph (c)(2) of this section, will ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the dietary supplement; and （3）您必须为确定与规范（拧）根据第（三）（1中选择符合您的基础上适当的文件）本条，通过适当的检查或根据第（三）（2举行的考试使用本节），将确保您的饮食补充完成一批符合身份，纯度，强度所有产品规格，和组成，以及对污染的可能掺假，或可能导致掺假这些类型的限制，的膳食补助金

(4) Your quality control personnel must review and approve the documentation that you provide under paragraph (c)(3) of this section. （4）您的质量管理人员必须审查和批准的文件 ， 你根据第（三）（第3条规定本节）。

(d)(1) You may exempt one or more product specifications from verification requirements in paragraph (c)(1) of this section if you determine and document that the specifications you select under paragraph (c)(1) of this section for determination of compliance with specifications are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage. （四）（1）您可豁免本节的一个或多个在第（c）（1核查要求的产品规格）如果您决定和文件的规格你根据第（三）（1选择本节）的对符合规格的决心是无法验证的生产和过程控制系统 ， 其产生的膳食补充剂 ， 以满足豁免的产品规格 ， 也没有检验或检验批次的完成阶段免征产品规格等科学有效的方法。 In such a case, you must document why, for example, any component and in-process testing, examination, or monitoring, and any other information, will ensure that such exempted product specification is met without verification through periodic testing of the finished batch; and 在这种情况下，你必须文件为何，例如，任何组件和过程，测试，检验，或监测，以及任何其他信息，以确保这些豁免产品规格不符合核查通过对一批成品定期测试;和

(2) Your quality control personnel must review and approve the documentation that you provide under paragraph (d)(1) of this section. （2）您的质量管理人员必须审查和批准的文件 ， 你根据第（四）（1提供）本条。

(e) Before you package or label a product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must visually examine the product and have documentation to determine whether the specifications that you established under 111.70 (f) are met. （五）在你包装或标签的产品 ，

您将收到包装或作为膳食补充剂标签（和分配 ， 而不是返回到供应商），您必须视觉检查产品 ， 并在文档 ， 以确定是否规范 ， 你根据111.70条（f）得到满足。

(f)(1) Before you use packaging, you must, at a minimum, conduct a visual identification of the containers and closures and review the supplier's invoice, guarantee, or certification to determine whether the packaging specifications are met; and （六）（1）在您使用的包装，你必须至少进行一次封闭容器和视觉识别和审查供应商的发票，担保，或证明 ， 以确定是否符合规格的包装;及

(2) Before you use labels, you must, at a minimum, conduct a visual examination of the label and review the supplier's invoice, guarantee, or certification to determine whether label specifications are met. （2）在使用标签，您必须至少进行标签的视觉检查和审查供应商的发票，担保，或证明 ， 以确定是否符合规格标签。

(g) You must, at a minimum, conduct a visual examination of the packaging and labeling of the finished packaged and labeled dietary supplements to determine whether you used the specified packaging and applied the specified label. （七）必须至少，进行包装的视觉检查和成品包装和标签膳食补充剂 ， 以确定是否使用指定的包装和应用指定标签标识。

(h)(1) You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods. （八）（1）你必须确保测验和考试 ， 用于确定是否符合规格要求是恰当的，科学有效的方法。

(2) The tests and examinations that you use must include at least one of the following: （2）测验和考试 ， 您的使用必须至少包括以下之一：

(i) Gross organoleptic analysis; （一）总感官分析;

(ii) Macroscopic analysis; （二）宏观分析;

(iii) Microscopic analysis; （三）微观分析;

(iv) Chemical analysis; or （四）化学分析;或

(v) Other scientifically valid methods. （五）其他科学有效的方法。

(i) You must establish corrective action plans for use when an established specification is not met. （i）您使用必须建立纠正行动计划成立时不符合规范。

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007; 73 FR 27727, May 14, 2008] [72阻燃34942，2007年6月25日，截至72阻燃34968，2007年6月25日修订; 73阻燃27727，08年5月14日]

Sec. 秒。 111.77 What must you do if established specifications are not met? 111.77你做什么 ， 必须建立规范 ， 如果不能满足？

(a) For specifications established under 111.70(a), (b)(2), (b)(3), (c), (d), (e), and (g) that you do not meet, quality control personnel, in accordance with the requirements in subpart F of this part, must reject the component, dietary supplement, package or label unless such personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. （一）为根据111.70（一），（二）（2建立规范），（二）（3），（三），（四），（五），和（g），您不符合质量控制人员，按照本部分合伙的要求，必须摒弃组件，膳食补充剂，包装或标签 ， 除非这些人员通过一个进程的调整，或再加工 ， 以确保成品的膳食补充剂的质量待遇，而且膳食补充剂的包装和在主生产记录中指定的标记。 No finished batch of dietary supplements may be released for distribution unless it complies with 111.123(b). 没有完成的膳食补充剂可释放一批分发 ， 除非它符合111.123（b）项。

(b) For specifications established under 111.70(b)(1) that you do not meet, quality control personnel must reject the component and the component must not be used in manufacturing the dietary supplement. （b）下111.70（二）（1建立规范），您不符合质量控制人员必须拒绝组件和组件不能生产的膳食补充剂使用。

(c) For specifications established under 111.70(f) that you do not meet, quality control personnel must reject the product and the product may not be packaged or labeled for distribution as a dietary supplement. （三）为根据111.70条（f），你不符合，质量控制人员必须拒绝的产品和产品不得用于包装或作为膳食补充剂销售标规格。

Sec. 秒。 111.80 What representative samples must you collect? 111.80代表性的样本要什么你收集？

The representative samples that you must collect include: 代表性样品 ， 你必须收集包括：

(a) Representative samples of each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet specifications established in accordance with 111.70(b) and (d), and as applicable, 111.70(a) (and, when you receive components, packaging, or labels from a supplier, representative samples of each unique shipment, and of each unique lot within each unique shipment); （一）的代表样本 ， 每个组件，包装独特的很多，标签 ， 用于确定是否组成部分，包装和标签符合确立的111.70规范（二）和（d），以及适用，111.70（ 1）（并且，当您收到从供应商组成部分，包装或标签，有代表性的样本每个独特的转运，并在每一个独特的装运每一个独特的地段）;

(b) Representative samples of in-process materials for each manufactured batch at points, steps, or stages, in the manufacturing process as specified in the master manufacturing record where control is necessary to ensure the identity, purity, strength, and composition of dietary supplements to determine whether the in-process materials meet specifications established in accordance with 111.70(c), and as applicable, 111.70(a); （b）代表样品在加工材料的每个点，步骤或阶段制造的一批，在如主生产记录中指定在管制是必要的 ， 以确保自己的身份，纯度，强度制作过程和膳食组成补充 ， 以决定是否在进程材料符合确立的111.70规范（三），以及适用，111.70（1）;

(c) Representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications established in accordance with 111.70(e), and as applicable, 111.70(a); （三）对每一个膳食补充剂 ， 你制造的，你通过一个完善的统计抽样计划 ， 确定完成批次样品集代表（或每一批成品），然后分发给释放 ， 以验证对膳食补充剂的完成一批符合产品规格建立了111.70（e）和适用，按照111.70（1）;

(d) Representative samples of each unique shipment, and of each unique lot within each unique shipment, of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) to determine whether the received product meets specifications established in accordance with 111.70(f), and as applicable, 111.70(a); and （d）代表每一个独特的样本装运，并在每一个独特的装运您收到的产品包装或作为膳食补充剂的标签，每个独特的地段（和分配 ， 而不是返回到供应商），以确定是否收到产品符合确立的111.70规范（六），以及适用，111.70（a）和

(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with 111.70(g), and as applicable, 111.70(a). （五）各代表的大量样品包装和膳食补充剂标签 ， 以确定是否包装和成品包装和膳食补充剂标签符合确立的111.70规格标签（g）和适用，111.70（a）条。

Sec. 秒。 111.83 What are the requirements for reserve samples? 111.83哪些留样的要求？

(a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute. （1）您必须收集并保存每一个地段留样的包装和标签您分发膳食补充剂。

(b) The reserve samples must: （二）留样必须：

(1) Be held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere; （1）举行使用相同的容器封闭制度 ， 包装和标签的膳食补充剂的分配，或者分配膳食补充剂的包装和标签，使用容器密闭系统 ， 提供基本相同的特点 ， 防止污染或恶化 ， 在其所分配的包装和标签地方之一;

(2) Be identified with the batch, lot, or control number; （2）对同批次，批次，查出若干或控制;

(3) Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of

the last batch of dietary supplements associated with the reserve sample, for use in appropriate investigations; and （3）为保留过去的一年保质日期（如约会保质期使用），或2从与储备相关的膳食补充剂样本 ， 最后一批分配之年，在适当调查的使用;和

(4) Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications. （4）包括至少两次的数量为所有测试或检验 ， 以确定是否有必要的食品补充品符合产品规格。

Sec. 秒。 111.87 Who conducts a material review and makes a disposition decision? 111.87谁的材料进行审查并作出处理决定？

Quality control personnel must conduct all required material reviews and make all required disposition decisions. 质量控制人员必须进行所有必要的材料审查和作出一切必要的处置决定。

Sec. 秒。 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? 111.90什么要求适用于治疗，在进程的调整，和后处理当有偏差或意料之外的事件 ， 或当一个规范确立的111.70不满足？

(a) You must not reprocess a rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless: （1）你不能重新处理一膳食补充剂或拒绝治疗或提供一个进程调整组件，包装或标签 ， 使之适合于一个膳食补充剂的制造 ， 除非：

(1) Quality control personnel conduct a material review and make a disposition decision to approve the reprocessing, treatment, or in-process adjustment; and （1）质量控制人员进行材料进行审查并作出处理决定批准后处理，治疗，或在进程调整;和 (2) The reprocessing, treatment, or in-process adjustment is permitted by 111.77; （2）加工，处理，或者在进程调整允许111.77;

(b) You must not reprocess any dietary supplement or treat or provide an in-process adjustment to a component to make it suitable for use in the manufacture of a dietary supplement, unless: （b）您不能重新处理任何膳食补充剂或治疗 ， 或提供一个进程内组件调整 ， 使其适合于一个膳食补充剂生产使用，除非：

(1) Quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approves the reprocessing, treatment, or in-process adjustment; and （1）质量控制人员进行材料进行审查并作出处理决定是基于科学的正当理由 ， 并批准后处理，治疗，或在进程调整;和

(2) The reprocessing, treatment or in-process adjustment is permitted by 111.77; （2）加工，处理或过程的调整是允许111.77;

(c) Any batch of dietary supplement that is reprocessed, that contains components that you have treated, or to which you have made in-process adjustments to make them suitable for use in the manufacture of the dietary supplement must be approved by quality control personnel and comply with 111.123(b) before releasing for distribution. （三）任何膳食补充剂一批再行处理，包含您已处理，或您已在进程的调整 ， 使他们在对膳食补充剂的制造必须由适当的质量控制人员通过组件并遵守111.123（b）在分发释放。

Sec. 秒。 111.95 Under this subpart E, what records must you make and keep? 在这个子部分的位置111.95，什么记录必须保持你的？

(a) You must make and keep records required under this subpart E in accordance with subpart P of this part. （1）您必须制作并保存在此按照本部分附P附位置所需的记录。 (b) Under this subpart E, you must make and keep the following records: （二）根据本附的位置，你必须制作并保存以下记录：

(1) The specifications established; （1）规范建立;

百度搜索“77cn”或“免费范文网”即可找到本站免费阅读全部范文。收藏本站方便下次阅读，免费范文网，提供经典小说综合文库美国良好操作规范(4)在线全文阅读。