ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. View Preview in English (PDF) Give feedback about the content of this standard ISO 15378 - Primary Packaging Materials for Medicinal Products. ISO 15378 standard was developed by stakeholders in the pharmaceutical sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products. DIN EN ISO 15378:2016-03 identifies Good Manufacturing Practice (GMP) principles and specifies requirements for quality management system. ISO 15378 integrates the requirements of ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as Code of Federal regulations (U.S.), European directives and Indian regulations. Adhering to GMP principles boosts the efficiency of your production processes. DIN EN ISO 15378. ISO integrates the requirements of ISO as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as Code of Federal regulations U. 1537 2 Statutory and regulatory requirements can be expressed as legal requirements. OLFLYERS.COM Download Manual Reference and Free Ebook PDF Iso 15378 Manual PrintablePDF 2019 Iso 15378 Manual PrintablePDF 2019 is a well-liked ebook you need to have. The ISO 15378 Documentation kit - primary packaging material for medicinal products with reference to quality management system and GMP contains a set of total 150 editable word files. ISO 15378:2017 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. This