ISO 15378 specifies the quality management system (QMS) requirements for primary packaging materials for medicinal products, with particular focus on ISO 9001 requirements. The standard aims to enhance customer satisfaction through effectively applying the system, including processes for system improvement and conformity to customer, statutory and regulatory requirements.
Our experienced network of auditors can support and assess your compliance with ISO 15378.
Why choose an ISO 15378 certification audit from SGS?
We can help you:
- Confirm compliance with ISO 15378 requirements
- Demonstrate that you consistently provide products and services that meet customer and applicable statutory and regulatory requirements
- Confirm the quality of design, manufacturing and supply of primary packaging materials for medicinal products, with particular focus on ISO 9001 requirements and good manufacturing practices (GMP)
Aligning with the UN Sustainable Development Goals (SDGs)
ISO 15378 contributes to UN Sustainable Development Goal three.
Trusted ISO 15378 certification audits from a world leader
As the world’s leading certification, testing, verification and inspection company, we provide in-depth expertise in ISO 15378 requirements. We also provide a range of complementary services, including basic, internal auditor and standard clause interpretation training courses.