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Our ISO 15378 certification audit assesses your design, manufacturing and supply of primary packaging materials for medicinal products against the standard requirements.
Our ISO 15378 certification audit assesses your design, manufacturing and supply of primary packaging materials for medicinal products against the standard requirements.
ISO 15378 specifies the quality management system (QMS) requirements for primary packaging materials for medicinal products, with particular focus on ISO 9001 (QMS) 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.
We can help you:
ISO 15378 contributes to UN Sustainable Development Goal three.
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.
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