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
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
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?
organizations in the pharmaceutical sector to minimize or eliminate
instances of contamination, mix-ups, and errors
guidance on risk management and validation
to legal requirements
reduction and control of risks including contamination and manufacturing
efficiency and cost-effectiveness in operation
for Continual Improvement of Processes for overall improvements in
products and processes
Who can acquire ISO 15378:2017certification?
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.