Introduction
These guide​‌‌lines are intended to provide guidance regarding Good Manufacturing Practices for
cosmetic products. These guidelines have been prepared for consideration by the cosmetic
industry and take into account the specific needs of this sector. These guidelines offer
organi...更多Introduction
These guide​‌‌lines are intended to provide guidance regarding Good Manufacturing Practices for
cosmetic products. These guidelines have been prepared for consideration by the cosmetic
industry and take into account the specific needs of this sector. These guidelines offer
organizational and practical advice on the management of the human, technical and administrative
factors affecting product quality.
These guidelines have been written to allow them to be used following the flow of products from
receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a
‘principle’ is added to each major section.
Good Manufacturing Practices constitute the practical development of the quality assurance
concept through the description of the plant activities that are based on sound scientific judgement
and risk assessments. The objective of these GMP guidelines is to define the activities that enable
you to obtain a product that meets defined characteristics.
Documentation is an integral part of Good Manufacturing Practices.
介 绍
这份准则为化妆品良好生产规范做出指导，是适合化妆品行业并考虑了行业的具体要求，在人
员，技术和影响产品质量的综合因素方面提供了系统性的和实际性的建议。
这个指导是为了让员工遵守产品接收到装运的流程下如何去利用资源。为了达到此目的，在每
一个章节里都添加了“原则”这一栏。
良好生产规范中的质量保证发展观念是通过描述建立在科学有效的判定和风险评估上的工厂活
动来完成的，这份准则的目的是为了界定能让你获得达标产品的活动。
文件是 GMP 不可或缺的一部分。
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ISO22716:2007(E)
化妆品良好生产规范准则
1 Scope 范围
This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products
此国际标准为化妆品生产，控制，储存和装运提供指南
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel
engaged in the plant, nor do they cover aspects of protection of the environment. Safety and environmental aspects are
inherent responsibilities of the company and could be governed by local legislation and regulation.
这个标准包含产品质量的各个方面但不包括员工安全和对环境的保护方面，安全和环境保护是公司的应的责任，可
以通过当地的法律和法规加以管制
These guidelines are not applicable to research and development activities and distribution of finished products.
这些准则并不适用于设计和开发和产品营销活动。
2 Terms and definitions 术语和定义
For the purposes of this document, the following terms and definitions apply.
以下术语和定义对于本文件是适用的
2.1 acceptance criteria 接收标准
numerical limits, ranges, or other suitable measures for acceptance of test results
数值限度，范围或者其他可作为接受测试结果的方法
2.2 audit 审核
systematic and independent examination to determine whether quality activities and related results comply with planned
arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives
为获得审核证据并对其进行客观评价，以确定满足审核准则的程度而进行的 系统的、独立的、形成文件的过程。
2.3 Batch 批
defined quantity of raw material, packaging material or product issued from one process or series of processes so that it
could be expected to be homogeneous
从某个或多个操作获得的、认为是一致的特定数量的原料，包材或产品。
2.4 batch number 批号
distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch
单个数字，字母，或字母和数字结合的，用来指定识别一批产品的代码.
2.5bulk produc 散装产品
any product which has completed manufacturing stages up to, but not including, final packaging
经过所有制造工艺过程的产品，除了没有填充到独立包装的产品。
2.6Calibration 校准
set of operations that establish, under specified conditions, the relationship between values indicated by a measuring
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instrument or measuring system, or values represented by a material measure, and the corresponding known values of a
reference standard
在特定条件下，通过一系列操作在测量仪器或测量系统所指示的量值，或事物量具或参考事物表示的值，和按标准
实现的相应值间建立起一种关系。
2.7 change control 变更控制
internal organization and responsibilities relative to any planned change of one or several activities covered by the Good
Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and stored products correspond
to the defined acceptance criteria
为确保生产，包装，控制，储存符合接收标准，组织所作的内部机构、职责与 GMP 内容有关的任何计划的变动。
2.8Cleaning 清洗
all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating generally visible
dirt from a surface by means of the following combined factors, in variable proportions, such as chemical action,
mechanical action, temperature, duration of application
为确保达到洁净水平，隔离或消除表面赃物的所有操作。例如用化学作用，机械作用，温度，时间等方法。
2.9Complaint 投诉
external information claiming a product does not meet defined acceptance criteria
外部信息断言成品有质量缺陷。
2.10Contamination 接触污染
occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product
指在产品中发现任何不应出现化学的，物理的，生物的物质的事件。
2.11Consumables 耗材
materials such as cleaning agents and lubricants that are used up during cleaning, sanitization ormaintenance operations
指某些在清洁、**或维护中消耗的材料诸如清洁剂、润滑油等。
2.12contract acceptor 受托方
person, company or external organization carrying out an operation on behalf of another person, company or organization
代表某人、公司、组织实施操作的个人、公司或外部的组织。
2.13
Control 控制
verification that acceptance criteria are met 确认可接受准则得到满足
2.14
Deviation 偏差
internal organization an