美國化妝品良好生產規范指南
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).

聯邦食品，藥品和化妝品法案（The Federal Food, Drug and Cosmetic Act, 以下簡稱FD&C法案）禁止在州際直接貿易的化妝品是摻雜的或貼假標簽的情況。(Sec. 301)

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

以下4種情況下，化妝品被認為是可能摻雜的。(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.

客戶在使用過程中，由于化妝品本身含有或在包裝容器中有潛在的，對人體有害的成份而使用戶受到傷害的。

2. It contains filth.

本身含有不潔成份的。

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

本身含有禁用成份，例如：未認可的色素添加劑。

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

在不衛生條件下生產的，或保留的，可導致產品傷害用戶有害或被不潔成份所污染。

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

以下幾種情況下，化妝品被認為可能會認為貼假標簽。(Sec. 602)

1. False or misleading labeling.

虛假的標簽或存在誤導信息的標簽。

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

顯著違反了聯邦食品，藥品和化妝品法案的要求在標簽上聲明的信息要求。

3. Misleading container presentation or fill.

在容器上有誤導的信息。

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.

為了確定化妝生產廠家是否保留或發貨了摻雜的，或是貼假標簽的化妝品，和防止這些違反了FD&C法案生產的化妝品流入市場，法律給了FDA進入這些化妝品工廠檢查的權利，包括檢查相關工廠的設備，成品，原料，容器和標簽。（見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.

如果工廠嚴格的根據良好的操作規范（GMP）的要求生產，將最低限度的減少摻雜的或貼假標簽的情況。隨后的化妝品指導，引用于FDA檢查操作手冊（FDA's Inspection Operations Manual），可以作為指南，用來有效的進行自我檢查，除良好的檢查得分則意味著工廠執行了良好操作規范（GMP）的要求。

Guidelines   指南

1. Building and Facilities. Check whether

建筑物和設施：檢查是否

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.

用于生產或存放化妝品的建筑物應大小合適，設計和結構應保證設備進出不受阻礙，材料存放整潔，操作衛生以及正確的清潔和維護。

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

地面，墻壁和天花板結構表面應光滑，易于清潔，并保持干凈和良好狀況。

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.

安裝的固定位置，管道的滴水或者冷凝水不會污染化妝品原料，器具，以及與化妝品原料，散裝產品或成品接觸的設備的表面。

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

照明和排風系統應滿足預期員工操作和舒適的要求。

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，清洗和衛生設施，地面排水和廢水系統應充分滿足清潔操作的要求，和設備，器具的清潔要求，以及滿足員工的需要并易于讓員工保持個人清潔。

2. Equipment. Check whether:  

設備：檢查是否

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，中轉和灌裝過程使用的設備和器具應設計合理，使用的材料和工藝能防止腐蝕，污垢的堆積，以及被潤滑油，灰塵或者消毒劑污染。

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

器具，運送管道以及和化妝品接觸的設備表面應維護良好，并定期清潔和消毒。

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.

清潔和消毒后的便攜式設備和器具應妥善放置，與化妝品接觸的設備表面應罩住，防止飛濺，灰塵或其他污染物。

3. Personnel. Check whether:

員工：檢查是否

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

監督化妝品的生產或者控制的員工應具有一定的教育背景，培訓和/或經驗來執行制定的監督工作。

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.

為防止化妝品摻雜，與化妝品原料，散裝成品或化妝品接觸表面直接接觸的員工，應穿戴合適的工作服，手套，頭套等，并保持良好的個人清潔。

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

吃東西，喝水，或抽煙都應嚴格限制在制定的區域。

4. Raw Materials. Check whether:

原料：檢查是否

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.

原料和初級包裝材料在儲藏和處理時應防止它們混淆，被微生物或化學物質污染，或者暴露在過度熱/冷/陽光/潮濕的環境下而造成腐敗變質。

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

容器應保持密閉，袋裝或盒裝的材料應離地存放。

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

容器上應有標簽，說明批次和控制狀況。

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.

根據程序的要求對原料進行抽樣和測試，確保沒有受到污染，微生物或者其他外界物質的污染，以對防止成品的摻雜。應特別主要來源自與動物或植物的原料，或那些用冷加工方法生產的化妝品可能被污物或微生物污染的情況。

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

不符接收標準的原料應正確標識和控制，以防止他們使用在化妝品中。

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:

生產：檢查是否已經建立制造和控制的程序，并有書面的工作指導書。也就是，已制定了配方，加工過程，周轉和灌裝，以及加工中的控制方法等的作業指導書。確定這些程序是否要求。

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，周轉和灌裝工具，以及裝原料和散裝原料的容器要保持干凈，并維護良好和在衛生的狀況下。

2. Only approved materials are used.

僅使用被批準的原料。

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.

適當時，在加工過程中，和/或加工過程后，周轉當中，灌裝時對產品進行抽樣測試，以確定混合，或其他加工步驟，沒有受到有害微生物或化學物質的污染，并應符合的其他應接受的產品規范要求。

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

稱量和計量原料應由另外一個人來進行檢查，存放原料的容器應正確標識。

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，灌裝或存放化妝品的主要設備，周轉箱，容器應標識清楚，并說明內容物，批號，控制狀況和其他相關信息。

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

為避免混淆，貼標簽之前應對其他進行識別檢查。

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，周轉及灌裝的設備每批都進行標識，以確定批次和控制狀況。

8. Packages of finished products bear permanent code marks.

在成品的包裝上，應打上永久性編碼。

9. Returned cosmetics are examined for deterioration or contamination.

對退回的化妝品應進行是否變質或被污染的檢查。

6. Laboratory Controls. Check whether:

實驗室控制：檢查是否

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.

對原料，加工中的樣品和成品進行測試和檢查，以驗證他們符合產品規范對其物理和化學指針質，微生物的要求，以及沒有受到有害物質，或其他有害化學物質的污染。

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.

批準的每個批次的原料和成品的留樣，保留時間符合規定的保留時間的要求，并存放在正確的條件下，以防止其受到污染或變質，而且再次測試以確保他們符合驗收規范的要求。

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

供水系統，特別是在化妝品中作為原料的水，應定期測試，以確定他們符合化學性指針和微生物指標的要求。

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.

對成品的留樣，模擬使用者可能的存放條件和消費者使用時可能發生的微生物污染進行測試。

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

記錄：檢查控制記錄的是否保持

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

原料和初級包裝材料，歸檔不合格材料的處理數據。

2. Manufacturing of batches, documenting the:

每個生產批次，對以下文件進行歸檔：

1. Kinds, lots and quantities of material used.

所使用原料的種類，批次和數量

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

加工，處理，周轉，存放和灌裝

3. Sampling, controlling, adjusting and reworking.

抽樣，控制，調整和返工

4. Code marks of batches and finished products.

批次的成品的代碼標志

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

成品，抽樣記錄，實驗室檢驗，測試結果和控制狀況的文件

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

發貨，裝車，代碼標志和收件人

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

標簽：檢查標簽是否：

1. On the principal display panel:

在首要的顯示面有：

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

產品名稱，特性的說明和凈內容物

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.

如果該產品的安全性還未經驗證，應該有警示性聲明“警告—產品的安全性未經證明“，確定是否和該公司進行了哪方面的毒理性的和/或其他的測試來證明其產品的安全性。

2. On the information panel:

在信息的顯示面有：

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

生產廠家或者銷售公司的名稱和地址。

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

如果直接用于銷售，或者面向家庭使用的消費者銷售時，應標識成份清單（僅在容器外表面）

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要求的警告聲明。

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

其他必須的警告，或防止對健康有危害的聲明。確定健康的危害或與之為基礎的警告聲明。

5. Any direction for safe use of product.

產品的任何安全使用說明。

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.

對于染發產品，法案Sec.601(a)中要求，增加適當的聲明，指導初次使用者如何做測試。此項警告僅適用coal-tar的染發產品，如果有這樣的貼標，將不會違反法案中對摻假會被免于法案中對摻假的要求。

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

投訴：檢查公司是否保留消費者投訴的文件和確定：

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

每次報告的傷害事故種類和嚴重性以及涉及的身體部位。

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

每次與傷害事故相關的產品，包括制造商和編碼。

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

涉及的醫療處理措施，包括主治醫生的姓名。

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.

提供毒害數據信息的控制中心，政府機構和醫療單位等的名稱和所在地。

10. Other. Check whether the firm is:

其他：檢查公司是否

1. Participating in the program of voluntary registration of:

參與自愿性的注冊：

1. Cosmetic manufacturing establishments (21 CFR 710).

化妝品制造企業（21CFR710）

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

化妝品成份和化妝品原料成份組成的聲明（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).

使用沒有被列入化妝品中允許使用的色素添加劑(21 CFR 73, 74, and 82)或者那些沒有認可的色素添加劑（21CFR80）。

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

使用被禁止在化妝品中的使用成分（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.