What is ISO 15378:2017 (GMP)- Certification?


ISO 15378:2017 (GMP) is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. ISO 15378 requirements include compliance to ISO 9001 and Good Manufacturing Practice – GMP requirements applicable to primary packaging materials 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.


The ISO 15378:2017 – Primary Packaging Materials for Medicinal products was developed by stakeholders in the pharmaceutical sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products.


Why ISO 15378:2017certification is important?


A certificate to ISO 15378:2017 with its holistic approach to GMP and quality requirements, is recognized throughout the world. GMP is a set of rules that gives you the affirmation that your item is safe. GMP is responsible for the safety, efficiency, and quality of pharmaceutical products, cosmetic products and edible products and their primary packaging.

 It provides manufacturers of primary packaging materials with a suitable qualification for customer approval – as well as improving the organization’s image in the eyes of the authorities.


What are the benefits of ISO 15378:2017certification?
  • Helps organizations in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors
  • Provides guidance on risk management and validation
  • Good selling tool.
  • Compliance to legal requirements
  • Identification, reduction and control of risks including contamination and manufacturing errors
  • Improved efficiency and cost-effectiveness in  operation
  • Provision for Continual Improvement of Processes for overall improvements in products and processes


Who can acquire ISO 15378:2017certification?

ISO 15378:2017 applies to all manufacturers of packaging materials that come into direct contact with the medicinal products. The standard covers all the usual materials, such as glass, rubber, aluminum, and plastics.

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