2024年3月17日发(作者：)

什么要求适用于包装和标签的接收？

(a) You must visually examine each immediate container or grouping of

immediate containers in a shipment for appropriate content label, container

damage, or broken seals to determine whether the container condition may have

resulted in contamination or deterioration of the packaging and labels.

必须对包装和标签的容器进行外观检查，看其标签是否适合，包装或封条是否破损而

导致被污染或变质。

(b) You must visually examine the supplier's invoice, guarantee, or certification

in a shipment to ensure that the packaging or labels are consistent with your

purchase order.

必须检查这些包装和标签的相关文件，以确保与您的订单一致。

(c) You must quarantine packaging and labels before you use them in the

manufacture of a dietary supplement until:

在使用它们生产膳食补充剂之前必须标识待检。

(1) You collect representative samples of each unique shipment, and of each

unique lot within each unique shipment, of packaging and labels and, at a

minimum, conduct a visual identification of the immediate containers and

closures;

对每次到货的每批包装和标签收集代表性样品，至少对容器和密封件进行外观鉴别。

(2) Quality control personnel review and approve the results of any tests or

examinations conducted on the packaging and labels; and

质量控制人员审查和批准测试或检查的结果。

(3) Quality control personnel approve the packaging and labels for use in the

manufacture of a dietary supplement and release them from quarantine.

质量控制人员批准此包装和标签用到生产中，批准从待检区放行。

(d)(1) You must identify each unique lot within each unique shipment of

packaging and labels in a manner that allows you to trace the lot to the supplier,

the date received, the name of the packaging and label, the status of the

packaging and label (e.g., quarantined, approved, or rejected); and to the dietary

supplement that you distributed; and

必须对每次到货的每批包装和标签标识唯一批号，从此批号可以追溯到供货商，接货

时间，品名及状态（如待检、批准或拒绝），以及分销的膳食补充剂。

(2) You must use this unique identifier whenever you record the disposition of

each unique lot within each unique shipment of packaging and labels.

必须使用唯一的标识符记录每一个包装和标签独特的装运。

(e) You must hold packaging and labels under conditions that will protect

against contamination and deterioration, and avoid mixups.

必须将包装和标签保存在不会被污染，变质和混合的环境下。

Sec. 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)?

什么要求适用于成品包装或作为膳食补充剂标签的接收？

(a) You must visually examine each immediate container or grouping of

immediate containers in a shipment of product that you receive for packaging or

labeling as a dietary supplement (and for distribution rather than for return to the

supplier) for appropriate content label, container damage, or broken seals to

determine whether the container condition may have resulted in contamination or

deterioration of the received product.

必须对容器进行外观检查，看其标签是否适合，包装或封条是否破损而导致被污染或

变质。

(b) You must visually examine the supplier's invoice, guarantee, or certification

in a shipment of the received product to ensure that the received product is

consistent with your purchase order.

你必须视觉检查供应商的发票，担保，或一批收到的产品证明，以确保收到的产品是

否符合你的采购订单。

(c) You must quarantine the received product until:

在使用之前需进行待检，直到：

(1) You collect representative samples of each unique shipment, and of each

unique lot within each unique shipment, of received product;

对每次收货的每批收集代表性样品。

(2) Quality control personnel review and approve the documentation to

determine whether the received product meets the specifications that you

established under 111.70(f); and

质量控制人员审查和批准，并书面记录是否符合111.70 f规格。

(3) Quality control personnel approve the received product for packaging or

labeling as a dietary supplement and release the received product from

quarantine.

质量控制人员批准用到生产中，批准从待检区放行。

(d)(1) You must identify each unique lot within each unique shipment of

received product in a manner that allows you to trace the lot to the supplier, the

date received, the name of the received product, the status of the received product

(e.g., quarantined, approved, or rejected), and to the product that you packaged or

labeled and distributed as a dietary supplement.

必须对每次到货的每批货物标识唯一批号，从此批号可以追溯到供货商，接货时间，

品名及状态（如待检、批准或拒绝），以及做为膳食补充剂包装、标签和分销的产品。

(2) You must use this unique identifier whenever you record the disposition of

each unique lot within each unique shipment of the received product.

必须使用唯一的标识符记录每一个包装和标签独特的装运。

(e) You must hold the received product under conditions that will protect

against contamination and deterioration, and avoid mixups.

必须将接收的货物保存在不会被污染，变质和混合的环境下。

Sec. 111.170 What requirements apply to rejected components, packaging,

and labels, and to rejected products that are received for packaging or labeling as

a dietary supplement?

什么要求适用于拒绝组件、包装和标签，并拒绝收到的作为膳食补充剂的包装或标签？

You must clearly identify, hold, and control under a quarantine system for

appropriate disposition any component, packaging, and label, and any product

that you receive for packaging or labeling as a dietary supplement (and for

distribution rather than for return to the supplier), that is rejected and unsuitable

for use in manufacturing, packaging, or labeling operations.

你必须清楚的识别、持有和控制你收到的作为膳食补充剂的包装或标签（以及分布而

不是返回到供应商），进行适当的处置任何组件，包装，和标签，拒绝不适合使用在生产、

包装或标签操作。

Sec. 111.180 Under this subpart G, what records must you make and keep?

在这个部分G，你必须保存什么记录？

(a) You must make and keep records required under this subpart G in

accordance with subpart P of this part.

你必须根据P部分的要求填写和保存的记录

(b) You must make and keep the following records:

你必须制作并保存以下记录。

(1) Written procedures for fulfilling the requirements of this subpart.

根据此部分的要求制定的书面程序。

(2) Receiving records (including records such as certificates of analysis,

suppliers' invoices, and suppliers' guarantees) for components, packaging, and

labels and for products that you receive for packaging or labeling as a dietary

supplement (and for distribution rather than for return to the supplier); and

接收记录（包括质量分析、供应商的发票、和供应商的保证）组件。

(3) Documentation that the requirements of this subpart were met.

书面记录符合此部分的要求。

(i) The person who performs the required operation must document, at the

time of performance, that the required operation was performed.

操作人员必须边做边记录。

(ii) The documentation must include:

记录必须包括：

(A) The date that the components, packaging, labels, or products that you

receive for packaging or labeling as a dietary supplement were received;

接收货物的时间。

(B) The initials of the person performing the required operation;

最初的收货人。

(C) The results of any tests or examinations conducted on components,

packaging, or labels, and of any visual examination of product that you receive for

packaging or labeling as a dietary supplement; and

任何组分的测试或分析结果，包装，或标签，和所有你收到的作为膳食补充剂的包装

和标签的视觉检查记录。

(D) Any material review and disposition decision conducted on components,

packaging, labels, or products that you receive for packaging or labeling as a

dietary supplement.

进行审查和处理决定的组成部分，包括你所收到的作为膳食补充剂的包装或标签。

Subpart H--Production and Process Control System: Requirements for the

Master Manufacturing Record

生产和工艺控制系统：主生产记录的要求（工艺规程）

Sec. 111.205 What is the requirement to establish a master manufacturing

record?

建立一个主生产记录的要求是什么？

(a) You must prepare and follow a written master manufacturing record for

each unique formulation of dietary supplement that you manufacture, and for

each batch size, to ensure uniformity in the finished batch from batch to batch.

你必须制定并采用一个书面的主生产记录，用来记录你所生产的每一批独特的膳食补

充剂配方和每一批的批量大小，以确保成品批次的均匀性。

(b) The master manufacturing record must:

主生产记录必须：

(1) Identify specifications for the points, steps, or stages 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; and

必须辨识生产过程中每个需要受控的点、步骤和阶段的标准，以确保膳食补充剂的质

量，并且膳食补充剂的包装与贴标操作与主生产记录上的要求一致。

(2) Establish controls and procedures to ensure that each batch of dietary

supplement that you manufacture meets the specifications identified in

accordance with paragraph (b)(1) of this section.

指明控制和程序，以确保每一批膳食补充剂都符合既定规格。

(c) You must make and keep master manufacturing records in accordance with

subpart P of this part.

根据P部分的要求填写和保存记录。

Sec. 111.210 What must the master manufacturing record include?

主生产记录必须包括什么?

The master manufacturing record must include:

主生产记录必须包括：

The name of the dietary supplement to be manufactured and the strength,

concentration, weight, or measure of each dietary ingredient for each batch size;

每批膳食补充剂的品名、浓度、重量或计量。

A complete list of components to be used;

使用成分的完整列表;

(c) An accurate statement of the weight or measure of each component to be

used;

所用组分重量或计量的精确声明

(d) The identity and weight or measure of each dietary ingredient that will be

declared on the Supplement Facts label and the identity of each ingredient that

will be declared on the ingredients list of the dietary supplement;

列明在营养成分表或成分目录中需列明的各成分重量或计量

(e) A statement of any intentional overage amount of a dietary ingredient;

膳食成分的故意溢出量声明。

(f) A statement of theoretical yield of a manufactured dietary supplement

expected at each point, step, or stage of the manufacturing process where control

is needed to ensure the quality of the dietary supplement, and the expected yield

when you finish manufacturing the dietary supplement, including the maximum

and minimum percentages of theoretical yield beyond which a deviation

investigation of a batch is necessary and material review is conducted and

disposition decision is made;

生产膳食补充剂理论产量的声明，在预期生产过程的每一个点，每一步，或每个阶段，

必要的控制以确保膳食补充剂的质量。以及成品膳食补充剂预期收益率的声明，包括超过

该批次的偏差调查的理论产量最大和最小百分比是必要的，并进行审查材料和作出处理决

定；（理论与预期收率）

(g) A description of packaging and a representative label, or a cross-reference

to the physical location of the actual or representative label;

包装和代表性标签的描述。

(h) Written instructions, including the following:

以及其他本款要求的书面规定：

(1) Specifications for each 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;

每个需要受控的点、步骤和阶段的标准，以确保膳食补充剂的质量，并且膳食补充剂

的包装与贴标操作与主生产记录上的要求一致。

(2) Procedures for sampling and a cross-reference to procedures for tests or

examinations;

取样过程和交叉测试或检查过程

(3) Specific actions necessary to perform and verify points, steps, or stages 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.

关键控制点所必须的特定的行动：

(i) Such specific actions must include verifying the weight or measure of any

component and verifying the addition of any component; and

核实任何组分的重量或计量和其它添加的组分。

(ii) For manual operations, such specific actions must include:

手动操作，此类具体行动必须包括：

(A) One person weighing or measuring a component and another person

verifying the weight or measure; and

一个人称量或测量一种成分时，另一个人验证核实其重量或比例；

(B) One person adding the component and another person verifying the

addition.

一个人添加组分时，另一个人核实添加量。

(4) Special notations and precautions to be followed; and

写明注意事项以及要遵循的预防措施；

(5) Corrective action plans for use when a specification is not met.

纠正预防措施

Subpart I--Production and Process Control System: Requirements for the

Batch Production Record

生产和工艺控制系统：批生产记录的要求

Sec. 111.255 What is the requirement to establish a batch production record?

建立批生产记录的要求是什么？

(a) You must prepare a batch production record every time you manufacture a

batch of a dietary supplement;

必须为生产的每批膳食补充剂编写书面的批生产记录

(b) Your batch production record must include complete information relating

to the production and control of each batch;

批生产记录必须包括每个批次的生产和控制的完整信息。

(c) Your batch production record must accurately follow the appropriate

master manufacturing record and you must perform each step in the production

of the batch; and

批生产记录必须准确地遵循相应的主生产记录，并对生产中的每一步进行记录。

(d) You must make and keep batch production records in accordance with

subpart P of this part.

必须按照p部分的要求制定并保存批生产记录。

Sec. 111.260 What must the batch record include?

批生产记录必须包括的内容有哪些？

The batch production record must include the following:

批生产记录必须包括以下内容：

(a) The batch, lot, or control number:

批次、批号或编号

(1) Of the finished batch of dietary supplement; and

成品的批号，以及

(2) That you assign in accordance with 111.415(f) for the following:

根据111.415（f）部分内容为下列产品分配的号码：

(i) Each lot of packaged and labeled dietary supplement from the finished

batch of dietary supplement;

从分包装商处接收的膳食补充剂；

(ii) Each lot of dietary supplement, from the finished batch of dietary

supplement, that you distribute to another person for packaging or labeling;

(ii) 你将分销给其他人进行包装或贴标的膳食补充剂；

(b) The identity of equipment and processing lines used in producing the

batch;

列明使用的设备和生产线

(c) The date and time of the maintenance, cleaning, and sanitizing of the

equipment and processing lines used in producing the batch, or a cross-reference

to records, such as individual equipment logs, where this information is retained;

生产批量产品时所用设备及加工线的维护、清洗、消毒的时间与日期，或记录的交叉

使用，如个别设备日志,该信息要保留;

(d) The unique identifier that you assigned to each component (or, when

applicable, to a product that you receive from a supplier for packaging or labeling

as a dietary supplement), packaging, and label used;

分配给每个组分（或适用时，从供应商处收到作为膳食补充剂进行包装或贴标的产品），

包装和所用标签的唯一标识；

(e) The identity and weight or measure of each component used;

所用每种组分的标识、重量或计量

(f) A statement of the actual yield and a statement of the percentage of

theoretical yield at appropriate phases of processing;

实际收率说明，一定加工阶段中理论产量百分比的说明

(g) The actual results obtained during any monitoring operation;

在任何监测操作过程中获得的实际结果

(h) The results of any testing or examination performed during the batch

production, or a cross-reference to such results;

在批生产过程中进行的任何测试或检查的结果，或这些结果的交叉对照

(i) Documentation that the finished dietary supplement meets specifications

established in accordance with 111.70(e) and (g);

书面记录成品要符合111.70，按照（e）和（g）规格

(j) Documentation, at the time of performance, of the manufacture of the

batch, including:

记录执行所有生产的人员和日期，包括：

(1) The date on which each step of the master manufacturing record was

performed; and

完成基本生产记录中每步工作的日期；

(2) The initials of the persons performing each step, including:

完成每步工作人员的首字母签名，包括：

(i) The initials of the person responsible for weighing or measuring each

component used in the batch;

负责对一批产品中所占用组分进行称重或计量的人员签名；

(ii) The initials of the person responsible for verifying the weight or measure of

each component used in the batch;

负责复核一批产品中所用各组分重量或量度结果的人员签名；

(iii) The initials of the person responsible for adding the component to the

batch; and

向一批产品中添加组分的负责人员的签名；

(iv) The initials of the person responsible for verifying the addition of

components to the batch;

复核一批产品中添加组分情况的负责人员的签名；

(k) Documentation, at the time of performance, of packaging and labeling

operations, including:

记录执行所有包装和贴标操作的人员和日期，包括：

(1) The unique identifier that you assigned to packaging and labels used, the

quantity of the packaging and labels used, and, when label reconciliation is

required, reconciliation of any discrepancies between issuance and use of labels;

使用包装和标签的唯一识别符，数量。

(2) An actual or representative label, or a cross-reference to the physical

location of the actual or representative label specified in the master manufacturing

record; and

与主生产记录一致的包装描述和代表性标签

(3) The results of any tests or examinations conducted on packaged and

labeled dietary supplements (including repackaged or relabeled dietary

supplements), or a cross-reference to the physical location of such results;

对已进行包装并贴标签的膳食补充剂所进行测试或检验得到的结果（包括重新包装和

重新贴标签的膳食补充剂），或此类结果实际位置的交叉对照

(l) Documentation at the time of performance that quality control personnel:

质量控制人员完成下列工作时的记录：

(1) Reviewed the batch production record, including:

审核批生产记录包括：

(i) Review of any monitoring operation required under subpart E of this part;

and

对本部分E节所要求监测作业的审核；

(ii) Review of the results of any tests and examinations, including tests and

examinations conducted on components, in-process materials, finished batches of

dietary supplements, and packaged and labeled dietary supplements;

审查的任何测试和检验结果，包括对组分、中间材料、膳食补充剂成品的批次，以及

包装并标签膳食补充剂进行的测试及检验；

(2) Approved or rejected any reprocessing or repackaging; and

批准或拒绝任何再加工或重新包装

(3) Approved and released, or rejected, the batch for distribution, including

any reprocessed batch; and

批准并放行或拒绝，批量分发，包括任何再加工批次

(4) Approved and released, or rejected, the packaged and labeled dietary

supplement, including any repackaged or relabeled dietary supplement.

批准和放行,或拒绝,包装和标签的膳食补充剂,包括任何重新包装或重新贴标签于膳食

补充剂。

(m) Documentation at the time of performance of any required material

review and disposition decision.

完成任何必需材料审核及做出处理决定时的文件。

(n) Documentation at the time of performance of any reprocessing.

完成任何重新加工时的文件。

Subpart J--Production and Process Control System: Requirements for

Laboratory Operations

生产和工艺控制系统：实验室运行的要求

Sec. 111.303 What are the requirements under this subpart J for written

procedures?

在这部分中书面程序的要求有哪些？

You must establish and follow written procedures for laboratory operations,

including written procedures for the tests and examinations that you conduct to

determine whether specifications are met.

必须建立和遵循实验室管理的书面程序，包括指导进行检测和检查的书面程序，这些

书面程序指导我们判断是否符合规范的要求。

Sec. 111.310 What are the requirements for the laboratory facilities that you

use?

所使用的实验室设施（仪器设备）的要求有哪些？

You must use adequate laboratory facilities to perform whatever testing and

examinations are necessary to determine whether:

必须有合适的实验室设备，来执行必要的检测和检查，以确定是否遵守如下情况：

(a) Components that you use meet specifications;

所用原料都能满足规格要求

(b) In-process specifications are met as specified in the master manufacturing

record; and

中间产品的检测满足主生产记录中的规定;和

(c) Dietary supplements that you manufacture meet specifications.

生产的膳食补充剂成品符合规范

Sec. 111.315 What are the requirements for laboratory control processes?

实验室控制过程有哪些要求？

You must establish and follow laboratory control processes that are reviewed

and approved by quality control personnel, including the following:

必须由质量控制人员对已建立的实验室控制规程进行审核和批准，包括：

(a) Use of criteria for establishing appropriate specifications;

必须建立标准能够判定是否建立了适当的规格

(b) Use of sampling plans for obtaining representative samples, in accordance

with subpart E of this part, of:

使用抽样计划获得有代表性的样品，此部分内容与E部分的一致。

(1) Components, packaging, and labels;

成分（组成），包装和标签

(2) In-process materials;

中间产品

(3) Finished batches of dietary supplements;

膳食补充剂的成品

(4) Product that you receive for packaging or labeling as a dietary supplement

(and for distribution rather than for return to the supplier); and

从包装商处接收的膳食补充剂

(5) Packaged and labeled dietary supplements.

已经包装和贴签的膳食补充剂。

(c) Use of criteria for selecting appropriate examination and testing methods;

利用标准选择合适的检查和检测方法

(d) Use of criteria for selecting standard reference materials used in

performing tests and examinations; and

利用标准选择合适的标准参照品（标准品），进行检测和检查。

(e) Use of test methods and examinations in accordance with established

criteria.

使用的测试方法和检查要符合既定标准

Sec. 111.320 What requirements apply to laboratory methods for testing and

examination?

适用于检测和检查的实验室方法有什么要求？

(a) You must verify that the laboratory examination and testing

methodologies are appropriate for their intended use.

必须验证该实验室检查和检测方法学适用于预期的用途。

(b) You must identify and use an appropriate scientifically valid method for

each established specification for which testing or examination is required to

determine whether the specification is met.

必须确定和使用一个适当的科学有效的方法，建立每个检测和检查规范。这些检测和

检查规范需要确定是否满足要求。

Sec. 111.325 Under this subpart J, what records must you make and keep?

在这个部分中什么样的记录必须做并且要保留。

(a) You must make and keep records required under this subpart J in

accordance with subpart P of this part.

必须记录和保留下此部分内容 ，与文中P部分关于此内容的要求一致。

(b) You must make and keep the following records:

必须制作并保存以下记录：

(1) Written procedures for laboratory operations, including written procedures

for the tests and examinations that you conduct to determine whether

specifications are met;

建立实验室操作书面规程，包括用来指导判定是否符合规范的检测或检查的书面规程。

(2) Documentation that laboratory methodology established in accordance

with this subpart J is followed.

书面记录根据子部 J建立的实验室方法

(i) The person who conducts the testing and examination must document, at

the time of performance, that laboratory methodology established in accordance

with this subpart J is followed.

做检测和检查的人员和执行时间必须记录下来，边做边记录，实验室的方法建立要与

J中此内容一致。

(ii) The documentation for laboratory tests and examinations must include the

results of the testing and examination.

记录测试和检查的所有结果

Subpart K--Production and Process Control System: Requirements for

Manufacturing Operations

生产和工艺控制系统：生产运行的要求

Sec. 111.353 What are the requirements under this subpart K for written

procedures?

K这一部分是写的什么程序要求？

You must establish and follow written procedures for manufacturing

operations.

你必须制定并遵循书面的生产作业运行程序

Sec. 111.355 What are the design requirements for manufacturing operations?

生产操作的设计要求是什么？

You must design or select manufacturing processes to ensure that product

specifications are consistently met.

生产程序的设计或选择必须确保始终符合产品规范要求

Sec. 111.360 What are the requirements for sanitation?

环境卫生要求是什么？

You must conduct all manufacturing operations in accordance with adequate

sanitation principles.

必须在足够的卫生总则条件下执行所有生产操作

Sec. 111.365 What precautions must you take to prevent contamination?

你必须采取什么预防措施来防止污染？

You must take all the necessary precautions during the manufacture of a

dietary supplement to prevent contamination of components or dietary

supplements. These precautions include:

在生产膳食补充剂过程中你必须采取所有必要的预防措施来防止污染。这些措施包括：

(a) Performing manufacturing operations under conditions and controls that

protect against the potential for growth of microorganisms and the potential for

contamination;

生产操作必须在能防止潜在微生物滋生和污染的环境和控制下进行。

(b) Washing or cleaning components that contain soil or other contaminants;

冲洗或清洁含有土壤或污染物的组分

(c) Using water that, at a minimum, complies with the applicable Federal, State,

and local requirements and does not contaminate the dietary supplement when

the water may become a component of the finished batch of dietary supplement;

在水分可能成为批量成品组分的情况下，用水至少应达到联邦、州及地方规定要求，

不得污染膳食补充剂；

(d) Performing chemical, microbiological, or other testing, as necessary to

prevent the use of contaminated components;

必要时应采用化学、微生物或其他检测防止使用被污染的成分

(e) Sterilizing, pasteurizing, freezing, refrigerating, controlling hydrogen-ion

concentration (pH), controlling humidity, controlling water activity (aw), or using

any other effective means to remove, destroy, or prevent the growth of

microorganisms and prevent decomposition;

使用消毒、巴氏灭菌、冷冻、冷藏、控制PH值,控制湿度,控制水分,或者使用其他有效

手段去除,破坏,或防止微生物的生长和腐烂变质;

(f) Holding components and dietary supplements that can support the rapid

growth of microorganisms of public health significance in a manner that prevents

the components and dietary supplements from becoming adulterated;

对能快速增长微生物的成分和膳食补充剂必须进行控制，以防止其变为掺假物

(g) Identifying and holding any components or dietary supplements, for which

a material review and disposition decision is required, in a manner that protects

components or dietary supplements that are not under a material review against

contamination and mixups with those that are under a material review;

当对物料审查和进行处理决定时，必须对其进行控制，以防止与正常的物料互混。

对于需要材料审核及做出处理决定的组分或膳食补充剂，其识别与保存应能够防止组

分或膳食补充剂在进行材料审核时不受到污染，并且不与材料审核中其它物品混合；

(h) Performing mechanical manufacturing steps (such as cutting, sorting,

inspecting, shredding, drying, grinding, blending, and sifting) by any effective

means to protect the dietary supplements against contamination, by, for example:

当进行人工操作（例如切割、挑选、检查、切碎、干燥、磨碎、混合、筛选）时，必

须有效防止污染。例如：

(1) Cleaning and sanitizing contact surfaces;

对接触面进行清洁消毒

(2) Using temperature controls; and

使用温度控制器

(3) Using time controls.

使用时间控制器

(i) Using effective measures to protect against the inclusion of metal or other

foreign material in components or dietary supplements, by, for example:

使用有效的措施来防止金属或其他外来异物进入膳食补充剂中。例如：

(1) Filters or strainers,过滤器

(2) Traps,分离器

(3) Magnets, or磁力棒

(4) Electronic metal detectors.电子金属探测仪

(j) Segregating and identifying all containers for a specific batch of dietary

supplements to identify their contents and, when necessary, the phase of

manufacturing; and

在生产过程中所有的容器，必须标明其内含物并隔离

(k) Identifying all processing lines and major equipment used during

manufacturing to indicate their contents, including the name of the dietary

supplement and the specific batch or lot number and, when necessary, the phase

of manufacturing.

在生产过程中，生产线上的主要设备必须标明其内含物，包括品名，标示符或批号。

Sec. 111.370 What requirements apply to rejected dietary supplements?

什么要求适用于不合格的膳食补充剂？

You must clearly identify, hold, and control under a quarantine system for

appropriate disposition any dietary supplement that is rejected and unsuitable for

use in manufacturing, packaging, or labeling operations.

你必须有清楚的辨别、保存和控制生产包装或贴标过程中产生的不合格膳食补充剂的

系统。

Sec. 111.375 Under this subpart K, what records must you make and keep?

在附录K里面，你必须整理和保存什么记录？

(a) You must make and keep records required under this subpart K in

accordance with subpart P of this part.

你必须根据附录P的要求记录和保存附录K这一部分所需要的档案

(b) You must make and keep records of the written procedures for

manufacturing operations.

你必须整理和存放加工生产过程形成的书面程序和记录

Subpart L--Production and Process Control System: Requirements for

Packaging and Labeling Operations

生产和工艺控制系统：包装和标签操作的要求

Sec. 111.403 What are the requirements under this subpart L for written

procedures?

L节中对于书面程序有什么要求？

You must establish and follow written procedures for packaging and labeling

operations.

你必须制定并遵循书面的包装及标签粘贴作业程序。

Sec. 111.410 What requirements apply to packaging and labels?

对于包装及标签有什么要求？

(a) You must take necessary actions to determine whether packaging for

dietary supplements meets specifications so that the condition of the packaging

will ensure the quality of your dietary supplements;

(a) 必须确定包装是否符合要求，包装条件是否能确保产品的质量。

(b) You must control the issuance and use of packaging and labels and

reconciliation of any issuance and use discrepancies. Label reconciliation is not

required for cut or rolled labels if a 100-percent examination for correct labels is

performed by appropriate electronic or electromechanical equipment during or

after completion of finishing operations; and

(b) 您必须控制包装与标签的发放及使用，核对发放与使用的数量平衡。如果在完成

操作期间或之后使用适当的电子或电机设备对正确标签完成了100%的检查，则不需要对

裁切或轧制标签进行标签核对；

(c) You must examine, before packaging and labeling operations, packaging

and labels for each batch of dietary supplement to determine whether the

packaging and labels conform to the master manufacturing record; and

(c) 在包装及粘贴标签之前，您必须检查每批膳食补充剂的包装与标签，确定这些包

装及标签是否符合主生产记录要求；

(d) You must be able to determine the complete manufacturing history and

control of the packaged and labeled dietary supplement through distribution.

(d)在销售膳食补充剂过程中，您必须确定完整的生产记录及包装和标签可控；

Sec. 111.415 What requirements apply to filling, assembling, packaging,

labeling, and related operations?

对于灌装，装配，包装，贴标和相关操作有什么要求？

You must fill, assemble, package, label, and perform other related operations

in a way that ensures the quality of the dietary supplement and that the dietary

supplement is packaged and labeled as specified in the master manufacturing

record. You must do this using any effective means, including the following:

在完成灌装，装配，包装，贴标和相关操作时，你必须确保膳食补充剂的质量，保证

如主生产记录所述进行包装并粘贴标签。你必须采取有效方式完成这项工作，包括：

(a) Cleaning and sanitizing all filling and packaging equipment, utensils, and

dietary supplement packaging, as appropriate;

(a) 对所有灌装，包装的设备、器具及膳食补充剂的包装进行清洁、消毒；

(b) Protecting manufactured dietary supplements from contamination,

particularly airborne contamination;

(b) 防止生产的膳食补充剂受到污染，尤其是空气污染；

(c) Using sanitary handling procedures;

(c) 采用卫生处理程序；

(d) Establishing physical or spatial separation of packaging and label

operations from operations on other components and dietary supplements to

prevent mixups;

(d) 必须将包装和贴标操作与其它组分和膳食补充剂物理或空间分离，以防止污染。

(e) Identifying, by any effective means, filled dietary supplement containers

that are set aside and held in unlabeled condition for future label operations, to

prevent mixups;

(e) 用任何有效方法，对备用和未贴标签的环境下留待以后贴标的膳食补充剂进行标

识，以方式交叉混合。

(f) Assigning a batch, lot, or control number to:

(f) 必须对每一批膳食补充剂都指定一个批号、批次或控制号码；

(1) Each lot of packaged and labeled dietary supplement from a finished batch

of dietary supplement; and,

(1) 膳食补充剂批量成品中每组已进行包装并粘贴标签的膳食补充剂；

(2) Each lot of dietary supplement, from a finished batch of dietary

supplement, that you distribute to another person for packaging or labeling.

(2) 您将会委托给其他人进行包装或粘贴标签的膳食补充剂批量成品中的每组膳食补

充剂。

(g) Examining a representative sample of each batch of the packaged and

labeled dietary supplement to determine whether the dietary supplement meets

specifications established in accordance with 111.70(g); and

(g) 必须对每一批已包装和贴标的膳食补充剂的代表性样品进行检测，以判定膳食补

充剂是否符合111.70g的规格。

(h) Suitably disposing of labels and packaging for dietary supplements that

are obsolete or incorrect to ensure that they are not used in any future packaging

and label operations.

(h) 对于标识不清或淘汰的膳食补充剂标签及包装，应加以适当处理，以确保其不会

用于以后的包装及标签粘贴作业。

Sec. 111.420 What requirements apply to repackaging and relabeling?

对于重新包装及重新贴标有什么要求？

(a) You may repackage or relabel dietary supplements only after quality

control personnel have approved such repackaging or relabeling.

(a) 只有在得到质量控制人员批准之后，您才能对膳食补充剂重新包装或重新粘贴标

签。

(b) You must examine a representative sample of each batch of repackaged or

relabeled dietary supplements to determine whether the repackaged or relabeled

dietary supplements meet all specifications established in accordance with

111.70(g).

(b) 对每批重新包装或重新贴标膳食补充剂的代表性样品您都必须加以检验，确定这

些重新包装或重新贴标的膳食补充剂是否达到根据111.70(g)部分内容所制定规范的要求。

(c) Quality control personnel must approve or reject each batch of repackaged

or relabeled dietary supplement prior to its release for distribution.

(c) 质量控制人员必须在入市销售之前，批准或否决每批重新包装或重新粘贴标签的

膳食补充剂。

Sec. 111.425 What requirements apply to a packaged and labeled dietary

supplement that is rejected for distribution?

对于被拒收不能配送的重新包装及重新粘贴标签的膳食补充剂有什么要求？

You must clearly identify, hold, and control under a quarantine system for

appropriate disposition any packaged and labeled dietary supplement that is

rejected for distribution.

对于被退回不能投入配送的经重新包装及重新粘贴标签的膳食补充剂，你必须在检疫

系统下清晰标识、保存并加以控制，以便适当加以处理。

Sec. 111.430 Under this subpart L, what records must you make and keep?

在L节中，你必须完成并保存哪些记录？

(a) You must make and keep records required under this subpart L in

accordance with subpart P of this part.

(a) 必须按照本部分P节要求完成并保存L节所规定的记录。

(b) You must make and keep records of the written procedures for packaging

and labeling operations.

(b) 你必须完成并保存包装及标签粘贴的书面记录。

Subpart M--Holding and Distributing 仓储和分销

Sec. 111.453 What are the requirements under this subpart for M written

procedures?

M节中对于书面程序有什么要求？

You must establish and follow written procedures for holding and distributing

operations.

您必须制定并执行仓储和分销的书面程序。

Sec. 111.455 What requirements apply to holding components, dietary

supplements, packaging, and labels?

对于组分、膳食补充剂、包装及标签保存有什么要求？

(a) You must hold components and dietary supplements under appropriate

conditions of temperature, humidity, and light so that the identity, purity, strength,

and composition of the components and dietary supplements are not affected.

(a) 你必须在适当的温度、湿度计光照条件下保存组分及膳食补充剂，以使组分及膳

食补充剂的特性、纯度、效力及成分不会受到影响。

(b) You must hold packaging and labels under appropriate conditions so that

the packaging and labels are not adversely affected.

(b) 你必须将包装及标签保存在适当的条件之下，以使包装及标签不会受到不利影响。

(c) You must hold components, dietary supplements, packaging, and labels

under conditions that do not lead to the mixup, contamination, or deterioration of

components, dietary supplements, packaging, and labels.

(c) 您必须将组分、膳食补充剂、包装及标签的储存条件，不会导致组分、膳食补充

剂、包装与标签出现在混淆、污染或变质。

Sec. 111.460 What requirements apply to holding in-process material?

对中间体的储存有什么要求？

(a) You must identify and hold in-process material under conditions that

protect against mixup, contamination, and deterioration.

(a) 您必须对中间体进行标识，并保证仓储条件防止出现混合、污染及变质。

(b) You must hold in-process material under appropriate conditions of

temperature, humidity, and light.

(b) 您必须将中间体保存在适当温度、湿度及光照的条件下。

Sec. 111.465 What requirements apply to holding reserve samples of dietary

supplements?

对于膳食补充剂的留样储存有什么要求？

(a) You must hold reserve samples of dietary supplements in a manner that

protects against contamination and deterioration. This includes:

(a)膳食补充剂的留样储存必须能够防止污染与变质。其中包括：

(1) Holding the reserve samples under conditions consistent with product

labels or, if no storage conditions are recommended on the label, under ordinary

storage conditions; and

(1) 必须将保留样品保存在产品标签规定的条件下，如果标签上没有说明推荐存储条

件，则保存在一般存储条件下；以及

(2) 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 you distribute the dietary supplement for

packaging and labeling elsewhere.

(2) 对于已进行包装并粘贴标签的膳食补充剂，采用与分销到其它地方进行包装并贴

标相同的容器密闭系统，如果配送的膳食补充剂尚待包装及粘贴标签，则应采用与在别处

进行包装和标签粘贴的膳食补充剂具有实质性相同特性的容器密闭系统，以防止产品污染

或变质。

(b) You must retain reserve samples 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 samples, for use in appropriate

investigations.

(b) 你必须在保存期（如果采用了保存期）后1年，或保留样品相关膳食补充剂最后

一批产品销售后的2年时间内保存这些保留样品，以备调查之用。

Sec. 111.470 What requirements apply to distributing dietary supplements?

对于销售发运膳食补充剂有什么要求？

You must distribute dietary supplements under conditions that will protect the

dietary supplements against contamination and deterioration.

你必须在能够防止膳食补充剂遭到污染及变质的条件下销售发运这些产品。

Sec. 111.475 Under this subpart M, what records must you make and keep?

在M节中，您必须完成并保存哪些记录？

(a) You must make and keep records required under this subpart M

accordance with subpart P of this part.

(a) 必须按照本部分P节要求完成并保存M节所规定的记录。

(b) You must make and keep the following records:

(b) 您必须制作并保存下列记录；

(1) Written procedures for holding and distributing operations; and

(1) 仓储和销售的书面程序；以及

(2) Records of product distribution.

(2) 产品分销记录。

Subpart N--Returned Dietary Supplements 退货的膳食补充剂

in

Sec. 111.503 What are the requirements under this subpart N for written

procedures?

N节中对于书面程序有什么要求？

You must establish and follow written procedures to fulfill the requirements of

this subpart.

你必须制定并遵守书面程序以满足本部分的要求。

Sec. 111.510 What requirements apply when a returned dietary supplement is

received?

在收到退回的膳食补充剂时有什么要求？

You must identify and quarantine returned dietary supplements until quality

control personnel conduct a material review and make a disposition decision.

你必须标识被退回的膳食补充剂并完成审查工作，直到质量管理人员进行材料审核并

做出处理决定。

Sec. 111.515 When must a returned dietary supplement be destroyed, or

otherwise suitably disposed of?

什么时候必须销毁或以其它方式适当处理退回的膳食补充剂？

You must destroy, or otherwise suitably dispose of, any returned dietary

supplement unless the outcome of a material review and disposition decision is

that quality control personnel do the following:

你必须销毁或以其它方式适当处理退回的膳食补充剂，除非物料审核及处理意见的结

果是质量管理人员完成了下列工作：

(a) Approve the salvage of the returned dietary supplement for redistribution

or

(a) 批准回收退回的膳食补充剂，用于再次配送，或

(b) Approve the returned dietary supplement for reprocessing.

(b) 批准退回的膳食补充剂用于重新加工。

Sec. 111.520 When may a returned dietary supplement be salvaged?

什么时候可以回收退回的膳食补充剂？

You may salvage a returned dietary supplement only if quality control

personnel conduct a material review and make a disposition decision to allow the

salvage.

只有在质量管理人员进行材料审核并做出处理决定允许回收时，你方可回收被退回的

膳食补充剂。

Sec. 111.525 What requirements apply to a returned dietary supplement that

quality control personnel approve for reprocessing?

对于质量管理人员批准用于再加工的退回膳食补充剂有什么要求？

(a) You must ensure that any returned dietary supplements that are

reprocessed meet all product specifications established in accordance with

111.70(e); and

(a) 你必须确保用于再加工的被退回膳食补充剂达到根据111.70(e)部分内容所制定

的所有产品规范；

(b) Quality control personnel must approve or reject the release for

distribution of any returned dietary supplement that is reprocessed.

(b) 质量管理人员必须批准或否决任何再加工的被退回膳食补充剂用于配送。

Sec. 111.530 When must an investigation be conducted of your manufacturing

processes and other batches?

什么时候必须对你方生产程序及其它批次产品进行调查？

If the reason for a dietary supplement being returned implicates other batches,

you must conduct an investigation of your manufacturing processes and each of

those other batches to determine compliance with specifications.

如果一批膳食补充剂被退回的原因涉及到其它批次产品，你必须对生产程序及其它每

批产品进行调查，以确定其达标性。

Sec. 111.535 Under this subpart N, what records must you make and keep?

在N节中，你必须完成并保存哪些记录？

(a) You must make and keep records required under this subpart N in

accordance with subpart P of this part.

(a) 你必须按照本部分P节要求完成并保存N节所规定的记录。

(b) You must make and keep the following records:

(b) 你必须完成并保存以下记录：

(1) Written procedures for fulfilling the requirements of this subpart N.

(1) 满足N节要求的书面程序；

(2) Any material review and disposition decision on a returned dietary

supplement;

(2) 退回膳食补充剂的材料审核及处理决定；

(3) The results of any testing or examination conducted to determine

compliance with product specifications established under 111.70(e); and,

(3) 为确定产品是否达到111.70(e)部分所制定产品规范所进行测试或检验的结果；以

及

(4) Documentation of the reevaluation by quality control personnel of any

dietary supplement that is reprocessed and the determination by quality control

personnel of whether the reprocessed dietary supplement meets product

specifications established in accordance with 111.70(e).

(4) 关于质量管理人员再加工膳食补充剂进行再次评估，及质量管理人员确定再加工

膳食补充剂是否达到111.70(e)部分所制定产品规范的文件。

Subpart O--Product Complaints 产品投诉

Sec. 111.553 What are the requirements under this subpart O for written

procedures?

O节中对于书面程序有什么要求？

You must establish and follow written procedures to fulfill the requirements of

this subpart O.

你必须制定并遵守书面程序以满足O节要求。

Sec. 111.560 What requirements apply to the review and investigation of a

product complaint?

对于产品投诉的审核与调查有什么要求？

(a) A qualified person must:

(a) 合格人员必须：

(1) Review all product complaints to determine whether the product complaint

involves a possible failure of a dietary supplement to meet any of its specifications,

or any other requirements of this part 111, including those specifications and

other requirements that, if not met, may result in a risk of illness or injury; and

(1) 审查所有产品投诉，确定产品投诉是否涉及到膳食补充剂有未达到规范要求或111

部分中其它要求的情况，包括规范及其它如未达到可能导致疾病或伤害风险的要求；以及

(2) Investigate any product complaint that involves a possible failure of a

dietary supplement to meet any of its specifications, or any other requirements of

this part, including those specifications and other requirements that, if not met,

may result in a risk of illness or injury.

(2) 对于涉及到膳食补充剂有未达到规范要求或本部分其它要求的情况，包括规范及

其它如未达到可能出现生病或伤害风险的要求的产品投诉，应进行调查。

(b) Quality control personnel must review and approve decisions about

whether to investigate a product complaint and review and approve the findings

and followup action of any investigation performed.

(b) 质量管理人员必须审核并批准是否调查产品投诉，并审核和批准任何调查活动的

结论及后续措施。

(c) The review and investigation of the product complaint by a qualified

person, and the review by quality control personnel about whether to investigate a

product complaint, and the findings and followup action of any investigation

performed, must extend to all relevant batches and records.

(c) 产品投诉设和与调查应由合格人员完成，并由质量管理人员对是否调查产品投诉、

以及任何调查的结果及后续措施进行复核，并且该等复核应扩大到所有相关批次产品及记

录。

Sec. 111.570 Under this subpart O, what records must you make and keep?

在O节中，你必须完成并保存哪些记录？

(a) You must make and keep the records required under this subpart O in

accordance with subpart P of this part.

(a) 必须按照本部分P节要求完成并保存O节所规定的记录。

(b) You must make and keep the following records:

(b) 你必须完成并保存下列记录：

(1) Written procedures for fulfilling the requirements of this subpart,

(1) 满足本部分要求的书面程序，

(2) A written record of every product complaint that is related to good

manufacturing practice,

(2) 每个关于生产质量管理规范产品投诉的书面记录，

(i) The person who performs the requirements of this subpart must document,

at the time of performance, that the requirement was performed.

(i) 负责执行本节要求的人员必须在作业时记录所执行的要求。

(ii) The written record of the product complaint must include the following:

(ii) 产品投诉书面记录必须包括下列内容：

(A) The name and description of the dietary supplement;

(A) 膳食补充剂的名称与说明；

(B) The batch, lot, or control number of the dietary supplement, if available;

(B) 膳食补充剂的批号、组号或控制号（如果有）；

(C) The date the complaint was received and the name, address, or telephone

number of the complainant, if available;

(C) 收到投诉的日期，投诉人的姓名、地址或电话号码（如果有）；

(D) The nature of the complaint including, if known, how the product was

used;

(D) 投诉的性质，包括产品使用的方法（如果知道）；

(E) The reply to the complainant, if any; and

(E) 对于投诉的回复（如果已回复）；

(F) Findings of the investigation and followup action taken when an

investigation is performed.

(F) 如进行了调查，所获得的调查结果及后续措施。

Subpart P--Records and Recordkeeping 记录和记录的保存

Sec. 111.605 What requirements apply to the records that you make and keep?

对于你制作并保存的记录有什么要求？

(a) You must keep written records required by this part for 1 year past the shelf

life date, if shelf life dating is used, or 2 years beyond the date of distribution of the

last batch of dietary supplements associated with those records.

(a) 你必须在保质期（如果采用了保质期）后1年，或记录相关成品最后一批产品分销

后的2年时间内保存本部分要求的这些书面记录。

(b) Records must be kept as original records, as true copies (such as

photocopies, microfilm, microfiche, or other accurate reproductions of the original

records), or as electronic records.

(b) 必须保存原始记录，真实件的复印件（如影印件、微缩胶片、单片微缩胶片或其它

原始记录准确的复印件），或电子数据记录。

(c) All electronic records must comply with part 11 of this chapter.

(c) 所有电子数据记录必须符合本章11部分要求。

Sec. 111.610 What records must be made available to FDA?

必须向FDA提供哪些记录？

(a) You must have all records required under this part, or copies of such

records, readily available during the retention period for inspection and copying

by FDA when requested.

(a) 在保管期间，你必须备好本部分中要求的所有记录或记录的复印件，以备FDA检

查并复印。

(b) If you use reduction techniques, such as microfilming, you must make

suitable reader and photocopying equipment readily available to FDA.

(b) 如果你采用了缩小技术，如缩微拍摄，你必须为FDA提供适当的阅读器及复印设

备。

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.

Page last updated: 08/21/2015