ISO 15378

Primary Packaging Materials for Medicinal Products / GMP Reference

ISO 15378 specifies requirements for a quality management system for primary packaging materials for medicinal products, incorporating GMP principles.

Key Benefits of ISO 15378

  • Compliance with pharmaceutical packaging regulations
  • Reduced risk of product contamination
  • Access to pharmaceutical supply chain markets
  • Enhanced product safety and integrity
  • Alignment with regulatory authority requirements
  • Improved quality control processes

Who Should Apply?

  • Packaging manufacturers
  • Pharmaceutical companies
  • Medical device packaging

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