What is ISO 15378?

ISO 15378 is an international standard that adds requirements related to cosmetics/pharmaceutical packaging to ISO 9001 (Quality Management System) requirements. Manufacturers of cosmetic containers and direct pharmaceutical containers (vial, ampoule, rubber pancake, etc.) are certified.

What are the benefits of ISO 15378

ISO 15378 includes the requirements of integrated ISO 9001 + GMP (legal requirements for the cosmetics/pharmaceutical and medical device industries) + all relevant regulations and guidelines from the United States, the EU, India, etc
Expedition of Cosmetics Container Exporters to Overseas Markets.
Development of advanced manufacturing and quality control system for the production of cosmetics subsidiary materials and containers
Acquire competitive advantage, provide confidence in stakeholders
Proactive response to CGMP requirements(Supplier qualification)
Minimize risk and reduce failure costs with documented criteria

ISO 15378 Model