ISO 15378:2017

ISO 15378:2017 Quality Management System for Primary Packaging Products for Medicinal Products

ISO 15378:2017 outlines the requirements for a quality management system, ensuring organizations can consistently deliver primary packaging materials for medicinal products that meet customer requirements, including regulatory specifications and relevant international standards applicable to primary packaging materials.

This standard serves as an application standard for the design, manufacturing, and supply of primary packaging materials for medicinal products, making it suitable for certification purposes.

Benefits:

» Minimize or eliminate instances of contamination, mix-ups, and errors.
» Reassure business partners and customers of a commitment to quality.
» Protect customers from purchasing potentially ineffective or dangerous products.
» Significant reduction in production and service costs.
» Enhanced effectiveness and efficiency of services.
» Improved compliance with legal, regulatory, and contractual requirements.
» Thorough traceability of materials and finished products is maintained.
» Uplifted safety standards throughout the organization.
» Reduced operating costs by eliminating downtime related to health concerns.
» Compliance with legal, statutory, and regulatory requirements.
» Improved stakeholder relationships by safeguarding human health and property.
» Enhanced reputation of the organization in society.
» Improved risk management by raising awareness of health and safety issues.
» Increased business sustainability.