ISO22716标准(中英文对照)

INTERNATIONASTANDARD L国际标准ISO22716First edition2007-11-15第一版本发行于2007年11月15日Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on GoodManufacturing Practices化妆品—良好生产规范（GMP）准则ISO 22716:2007(E)标准号ISO22716:2007(E)Contents Page Introduction (1)1 Scope (1)2 Terms and definitions (1)3 Personnel (4)4 Premises (6)5 Equipment (8)6 Raw materials and packaging materials (10)7 Production (11)8 Finished products (14)9 Quality control laboratory (15)10 Treatment of product that is out of specification (17)11 Wastes (17)12 Subcontracting (18)13 Deviations (19)14 Complaints and recalls (19)15 Change control (19)16 Internal audit (20)17 Documentation (20)目录介绍 (1)1 范围 (1)2 术语和定义 (1)3 员工 (4)4 厂房 (6)5 设备 (8)6 原料和包材 (10)7 生产 (11)8 成品 (14)9 实验室质量控制制 (15)10 不合格品的处理.......................................................... .1711 废弃物 (17)12 外包 (18)13 偏差 (19)14 投诉和召回 (19)15 变更控制 (19)16 内审 (20)17 文档 (20)IntroductionThese guidelines 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。

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 measuringinstrument 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。