标准号：ISO 15378-2006
实施状态：作废
中文名称：药品的主要包装材料.以优秀制造实践为基准对ISO 9001:2000应用的特殊要求
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
被替代标准：ISO 15378-2011
代替标准：ISO/FDIS 15378-2005
采用标准：DIN EN ISO 15378-2007,IDT;DIN ISO 15378-2006,IDT;DIN ISO 15378-2004,IDT;BS EN ISO 15378-2006,IDT;EN ISO 15378-2007,IDT;prEN ISO 15378-2006,IDT;NF S93-200-2006,IDT;NF S93-200-2008,IDT;S93-200PR,IDT;SN EN ISO 15378-2007,IDT;OENORM EN ISO 15378-2007,IDT;OENORM EN ISO 15378-2007,IDT;PN-EN ISO 15378-2007,IDT;UNE-EN ISO 15378-2008,IDT;GOST R 53699-2009,IDT
起草单位：ISO/TC 76
标准简介：1.1 General
This International Standard 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.
In this International Standard the term “if appropriate” is used several times. When a requirement is qualified
by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise.
ISO 9001:2000, Quality management systems — Requirements
1.1 General
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory
requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for
continual improvement of the system and the assurance of conformity to customer and applicable regulatory
requirements.
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.
1.2 Application
This International Standard is an application standard for the design, manufacture and supply of primary
packaging materials for medicinal products. It is also applicable for certification purposes.
ISO 9001:2000, Quality management systems — Requirements
All requirements of this International Standard are generic and are intended to be applicable to all organizations,
regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and
its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these
exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or
responsibility, to provide product that meets customer and applicable regulatory requirements.
文件格式：PDF
文件大小：2.52MB
文件页数：68
（以上信息更新时间为：2019-11-22）
ISO 15378-2006 药品的主要包装材料.以优秀制造实践为基准对ISO 9001_2000应用的特殊要求.pdf
(2.52 MB)
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