ISO 15378:2006 医疗制品一次包装材料 伴随优良制造实施标准（GMP）的引用，采用ISO 9001-2000的特殊要求事项

标准编号：ISO 15378:2006

中文名称：医疗制品一次包装材料 伴随优良制造实施标准（GMP）的引用，采用ISO 9001-2000的特殊要求事项

英文名称：Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

发布日期：2006-03

标准范围

ISO 15378:2006规定了质量管理体系的要求，在该体系中，组织需要证明其有能力为药品提供始终如一地满足客户要求的初级包装材料，包括适用于初级包装材料的监管要求和国际标准。ISO 15378:2006是医药产品初级包装材料设计、制造和供应的应用标准。它也适用于认证目的。

ISO 15378:2006 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.ISO 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

标准预览图