ISO 15378 Primary Packaging Material For Medicinal Products

This 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.

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Benefits Of ISO 15378 Management System For Primary Packaging Material For Medicinal Products
  • Minimize or eliminate instances of contamination, mix-ups, and errors.
  • Reassure business partners and customers of commitment to quality
  • Protect customers from purchasing potentially ineffective or dangerous products
  • Production and service cost is reduced to lot extent.
  • Services become more effective and efficient in all manners
  • Improved legal and regulatory or contractual requirements compliance
  • Thorough traceability of material as well as finished product is maintained