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.
DS/EN ISO 15378-2012由丹麦标准化协会 DK-DS 发布于 2012-03-01,并于 2012-03-01 实施。
DS/EN ISO 15378-2012在国际标准分类中归属于: 11.040.01 医疗设备综合。
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