美國化妆品良好生产规范指南
February 12, 1997; Updated April 24, 2008

The Federal Food, Drug and Cosmetic Act¹ prohibits the introduction or delivery for introduction into interstate commerce of cosmetics that are adulterated or misbranded (Sec. 301).

联邦食品，药品和化妆品法案（The Federal Food, Drug and Cosmetic Act, 以下简称FD&C法案）禁止在州际直接贸易的化妆品是掺杂的或贴假标签的情况。(Sec. 301)

A cosmetic may be deemed adulterated (Sec. 601) for essentially four reasons, namely:

以下4种情况下，化妆品被认为是可能掺杂的。(Sec. 601)

1. It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.

客户在使用过程中，由于化妆品本身含有或在包装容器中有潜在的，对人体有害的成份而使用户受到伤害的。

2. It contains filth.

本身含有不洁成份的。

3. It contains a non-permitted, or in some instances non-certified, color additive.

本身含有禁用成份，例如：未认可的色素添加剂。

4. It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.

在不卫生条件下生产的，或保留的，可导致产品伤害用户有害或被不洁成份所污染。

A cosmetic may be deemed misbranded (Sec. 602) for reasons of:

以下几种情况下，化妆品被认为可能会认为贴假标签。(Sec. 602)

1. False or misleading labeling.

虚假的标签或存在误导信息的标签。

2. Failure to state prominently and conspicuously any information required by or under authority of this act.

显着违反了联邦食品，药品和化妆品法案的要求在标签上声明的信息要求。

3. Misleading container presentation or fill.

在容器上有误导的信息。

To determine whether cosmetic firms manufacture, hold or deliver for introduction into interstate commerce cosmetics that are adulterated or misbranded, and to prevent these and other practices violating Sec. 301 of the FD&C Act, the law gives the agency the authority to enter the establishments of such firms and inspect their facilities as well as all pertinent equipment, finished and unfinished materials, containers and labeling therein. See Sec. 704(a) of the FD&C Act.

为了确定化妆生产厂家是否保留或发货了掺杂的，或是贴假标签的化妆品，和防止这些违反了FD&C法案生产的化妆品流入市场，法律给了FDA进入这些化妆品工厂检查的权利，包括检查相关工厂的设备，成品，原料，容器和标签。（见Sec.704（a）of the FD&C Act。）

Rigorous adherence to good manufacturing practice minimizes the risk of adulteration or misbranding of cosmetics. The following cosmetic establishment instructions, excerpted from FDA's Inspection Operations Manual, may serve as guidelines for effective self-inspection. A good inspection score means that an establishment follows good manufacturing practice.

如果工厂严格的根据良好的操作规范（GMP）的要求生产，将最低限度的减少掺杂的或贴假标签的情况。随后的化妆品指导，引用于FDA检查操作手册（FDA's Inspection Operations Manual），可以作为指南，用来有效的进行自我检查，除良好的检查得分则意味着工厂执行了良好操作规范（GMP）的要求。

Guidelines   指南

1. Building and Facilities. Check whether

建筑物和设施：检查是否

1. Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.

用于生产或存放化妆品的建筑物应大小合适，设计和结构应保证设备进出不受阻碍，材料存放整洁，操作卫生以及正确的清洁和维护。

2. Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.

地面，墙壁和天花板结构表面应光滑，易于清洁，并保持干净和良好状况。

3. Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.

安装的固定位置，管道的滴水或者冷凝水不会污染化妆品原料，器具，以及与化妆品原料，散装产品或成品接触的设备的表面。

4. Lighting and ventilation are sufficient for the intended operation and comfort of personnel.

照明和排风系统应满足预期员工操作和舒适的要求。

5. Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.

供水，清洗和卫生设施，地面排水和废水系统应充分满足清洁操作的要求，和设备，器具的清洁要求，以及满足员工的需要并易于让员工保持个人清洁。

2. Equipment. Check whether:  

设备：检查是否

1. Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.

加工，盛放，中转和灌装过程使用的设备和器具应设计合理，使用的材料和工艺能防止腐蚀，污垢的堆积，以及被润滑油，灰尘或者消毒剂污染。

2. Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals.

器具，运送管道以及和化妆品接触的设备表面应维护良好，并定期清洁和消毒。

3. Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.

清洁和消毒后的便携式设备和器具应妥善放置，与化妆品接触的设备表面应罩住，防止飞溅，灰尘或其他污染物。

3. Personnel. Check whether:

员工：检查是否

1. The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/or experience to perform the assigned functions.

监督化妆品的生产或者控制的员工应具有一定的教育背景，培训和/或经验来执行制定的监督工作。

2. Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.

为防止化妆品掺杂，与化妆品原料，散装成品或化妆品接触表面直接接触的员工，应穿戴合适的工作服，手套，头套等，并保持良好的个人清洁。

3. Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.

吃东西，喝水，或抽烟都应严格限制在制定的区域。

4. Raw Materials. Check whether:

原料：检查是否

1. Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.

原料和初级包装材料在储藏和处理时应防止它们混淆，被微生物或化学物质污染，或者暴露在过度热/冷/阳光/潮湿的环境下而造成腐败变质。

2. Containers of materials are closed, and bagged or boxed materials are stored off the floor.

容器应保持密闭，袋装或盒装的材料应离地存放。

3. Containers of materials are labeled with respect to identity, lot identification and control status.

容器上应有标签，说明批次和控制状况。

4. Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.

根据程序的要求对原料进行抽样和测试，确保没有受到污染，微生物或者其他外界物质的污染，以对防止成品的掺杂。应特别主要来源自与动物或植物的原料，或那些用冷加工方法生产的化妆品可能被污物或微生物污染的情况。

5. Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.

不符接收标准的原料应正确标识和控制，以防止他们使用在化妆品中。

5. Production. Check whether manufacturing and control have been established and written instructions, i.e., formulations, processing, transfer and filling instructions, in-process control methods etc., are being maintained. Determine whether such procedures require that:

生产：检查是否已经建立制造和控制的程序，并有书面的工作指导书。也就是，已制定了配方，加工过程，周转和灌装，以及加工中的控制方法等的作业指导书。确定这些程序是否要求。

1. The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.

加工，周转和灌装工具，以及装原料和散装原料的容器要保持干净，并维护良好和在卫生的状况下。

2. Only approved materials are used.

仅使用被批准的原料。

3. Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.

适当时，在加工过程中，和/或加工过程后，周转当中，灌装时对产品进行抽样测试，以确定混合，或其他加工步骤，没有受到有害微生物或化学物质的污染，并应符合的其他应接受的产品规范要求。

4. Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.

称量和计量原料应由另外一个人来进行检查，存放原料的容器应正确标识。

5. Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.

用于加工，灌装或存放化妆品的主要设备，周转箱，容器应标识清楚，并说明内容物，批号，控制状况和其他相关信息。

6. Labels are examined for identity before labeling operations to avoid mix-up.

为避免混淆，贴标签之前应对其他进行识别检查。

7. The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status.

用于加工，存放，周转及灌装的设备每批都进行标识，以确定批次和控制状况。

8. Packages of finished products bear permanent code marks.

在成品的包装上，应打上永久性编码。

9. Returned cosmetics are examined for deterioration or contamination.

对退回的化妆品应进行是否变质或被污染的检查。

6. Laboratory Controls. Check whether:

实验室控制：检查是否

1. Raw materials, in-process samples and finished products are tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants.

对原料，加工中的样品和成品进行测试和检查，以验证他们符合产品规范对其物理和化学指针质，微生物的要求，以及没有受到有害物质，或其他有害化学物质的污染。

2. Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued compliance with established acceptance specifications.

批准的每个批次的原料和成品的留样，保留时间符合规定的保留时间的要求，并存放在正确的条件下，以防止其受到污染或变质，而且再次测试以确保他们符合验收规范的要求。

3. The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemical-analytical and microbiological specifications.

供水系统，特别是在化妆品中作为原料的水，应定期测试，以确定他们符合化学性指针和微生物指标的要求。

4. Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur user reasonably foreseeable condition of storage and consumer use.

对成品的留样，模拟使用者可能的存放条件和消费者使用时可能发生的微生物污染进行测试。

7. Records. Check whether control records are maintained of:

记录：检查控制记录的是否保持

1. Raw materials and primary packaging materials, documenting disposition of rejected materials.

原料和初级包装材料，归档不合格材料的处理数据。

2. Manufacturing of batches, documenting the:

每个生产批次，对以下文件进行归档：

1. Kinds, lots and quantities of material used.

所使用原料的种类，批次和数量

2. Processing, handling, transferring, holding and filling.

加工，处理，周转，存放和灌装

3. Sampling, controlling, adjusting and reworking.

抽样，控制，调整和返工

4. Code marks of batches and finished products.

批次的成品的代码标志

3. Finished products, documenting sampling, individual laboratory controls, test results and control status.

成品，抽样记录，实验室检验，测试结果和控制状况的文件

4. Distribution, documenting initial interstate shipment, code marks and consignees.

发货，装车，代码标志和收件人

8. Labeling. Check whether the labels of the immediate and outer container bear:

标签：检查标签是否：

1. On the principal display panel:

在首要的显示面有：

1. In addition to the name of the product, the statements of identity and net contents,

产品名称，特性的说明和凈内容物

2. The statement "Warning--The safety of this product has not been determined" if the safety of the respective product has not adequately been substantiated. Determine whether and what toxicological and/or other testing the firm has conducted to substantiate the safety of its products. See 21 CFR 740.10.

如果该产品的安全性还未经验证，应该有警示性声明“警告—产品的安全性未经证明“，确定是否和该公司进行了哪方面的毒理性的和/或其他的测试来证明其产品的安全性。

2. On the information panel:

在信息的显示面有：

1. The name and address of the firm manufacturing the product or introducing it into interstate commerce.

生产厂家或者销售公司的名称和地址。

2. the list of ingredients (only on outer container) if intended for sale or customarily sold to consumers for consumption at home.

如果直接用于销售，或者面向家庭使用的消费者销售时，应标识成份清单（仅在容器外表面）

3. The warning statement(s) required at 21 CFR 740.11, 740.12 and 740.17.

21 CFR 740.11, 740.12 和740.17要求的警告声明。

4. Any other warning statement necessary or appropriate to prevent a health hazard. Determine the health hazard or their basis for a warning statement.

其他必须的警告，或防止对健康有危害的声明。确定健康的危害或与之为基础的警告声明。

5. Any direction for safe use of product.

产品的任何安全使用说明。

6. In case of a hair dye product, the caution statement of Sec. 601(a) of the Act and appropriate directions for preliminary patch testing. This warning only applies to coal-tar hair dyes which, if so labeled, are then exempted from the adulteration provision of the Act.

对于染发产品，法案Sec.601(a)中要求，增加适当的声明，指导初次使用者如何做测试。此项警告仅适用coal-tar的染发产品，如果有这样的贴标，将不会违反法案中对掺假会被免于法案中对掺假的要求。

9. Complaints. Check whether the firm maintains a consumer complaint file and determine:

投诉：检查公司是否保留消费者投诉的文件和确定：

1. The kind and severity of each reported injury and the body part involved.

每次报告的伤害事故种类和严重性以及涉及的身体部位。

2. The product associated with each injury, including the manufacturer and code number.

每次与伤害事故相关的产品，包括制造商和编码。

1. The medical treatment involved, if any, including the name of the attending physician..

涉及的医疗处理措施，包括主治医生的姓名。

4. The name(s) and location(s) of any poison control center, government agency, physician's group etc., to whom formula information and/or toxicity data are provided.

提供毒害数据信息的控制中心，政府机构和医疗单位等的名称和所在地。

10. Other. Check whether the firm is:

其他：检查公司是否

1. Participating in the program of voluntary registration of:

参与自愿性的注册：

1. Cosmetic manufacturing establishments (21 CFR 710).

化妆品制造企业（21CFR710）

2. Cosmetic product ingredient and cosmetic raw material composition statements (21 CFR 720).

化妆品成份和化妆品原料成份组成的声明（21CFR720）。

2. Using a color additive which is not listed for use in cosmetics (21 CFR 73, 74, and 82) or which is not certified (21 CFR 80).

使用没有被列入化妆品中允许使用的色素添加剂(21 CFR 73, 74, and 82)或者那些没有认可的色素添加剂（21CFR80）。

3. Using a prohibited cosmetic ingredient (21 CFR 700).

使用被禁止在化妆品中的使用成分（21CFR700）

For important information on international approaches to Good Manufacturing Practice, please refer to International Cooperation on Cosmetic Regulation Outcome of Meeting², September 26-28, 2007.