东盟化妆品良好生产规范指南中英版本.doc

__________________________________________________________________________ ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE 东盟化妆品良好生产规范指南 Appendix VI – ASEAN Guidelines for Cosmetic Good Manufacturing Practice 附录6 -东盟化妆品良好生产规范指南 APPENDIX VI 附录6 ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE 东盟化妆品良好生产规范指南 PREAMBLE 序文 The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN cosmetic Directive. As this document is particularly intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP should be kept in mind. 已经有GMP指南为符合东盟化妆品指南规定的化妆品行业提供帮忙。由于本文专门用于化妆品，所以要谨记药品或药用物品GMP的清楚描述。 The Good Manufacturing Practices presented here is only a general guideline for the manufacturers to develop its own internal quality management system and procedures. The important objective must be met in any case, i.e. the final products must meet the quality standards appropriate to their intended use to assure consumer’s health and benefit. 这里介绍的良好生产规范只是为制造商提升内部质量管理系统和程序提供通用指南。任何情况下都要符合重要目标，例如成品必须达到符合它们的预期使用以确保消费者健康和利益的质量标准。 1. INTRODUCTION 介绍 The objective of the Cosmetic Good Manufacturing Practice ( GMP ) Guidelines is to ensure that products are consistently manufactured and controlled to the specified quality. It is concerned with all aspects of production and quality control. GMP指南的目标是确保如规定质量地一贯生产和控制产品。它涉及产品和质量控制的所有方面。 1.1 General Consideration 一般情况 1.1.1 In the manufacture of cosmetic products, overall control and monitoring is essential to ensure that the consumer receives products of high qual 在化妆品生产，为了让确保消费者获得高质量产品，必须全面控制和监控。 The quality of a product depends on the starting materials, production and quality control processes, building, equipment and personnel involved. 产品质量取决于起始原料、生产和质量控制过程、建立、设备和相关人员。 1.2 Quality Management System 质量管理系统 1.2.1 A quality system should be developed, established and implemented as