ISO22716标准(中英文 对照)

INTERNATIONA

STANDARD L国际标准ISO22716

First edition

2007-11-15

第一版本发行于

2007年11月15日

Cosmetics — Good Manufacturing

Practices (GMP) — Guidelines on Good

Manufacturing 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.......................................................... .17

11 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)

Introduction

These 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 each major section.

‘principle’ is added to

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。