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ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. General information. Complete editable ISO 15378:2017 document kit (Manual, procedures, exhibits, process approach, SOPs, formats, audit checklist etc.) Buy: EN ISO 15378:2017 - ISO 15378:2017 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to A certificate to ISO 15378, with its holistic approach to GMP and quality require- ments, is recognized throughout the world. It provides manufacturers of ISO 2017. Primary packaging materials for medicinal products — Particular 15378. Fourth edition. 2017-09. Reference number. ISO 15378:2017(E). application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) DIN EN ISO 15378 : 2018-04. ISO 15378 : 2017. EN ISO 15378 : 2017. Normative base. ISO 15378:2017. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015,. 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

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