ISO 15378:2017 Quality Management System for Primary Packaging Products 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 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.


  • 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
  • Standard of safety throughout the organization is uplifted
  • Operating cost is reduced by reducing or eliminating down time in terms of health concerns
  • Compliance with legal, statutory and regulatory requirements
  • Improved stakeholder relationships - by safeguarding the human health and property
  • Reputation of organization is improved in society
  • Improved risk management by making people aware about health and safety related issues
  • Business sustainability is increased