最新的美国化妆品良好生产规范指南(GMP)

最新的美国化妆品良好生产规范指南(GMP)

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

a.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.