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.
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。

b.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。

c.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。

d.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。

e.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
a.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。

b.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。

c.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
a.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。

b.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。

c.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
a.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.。