ISO 15378
**ISO 15378**
What is ISO 15378?
ISO 15378:2017 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide medicinal products that meet customer and applicable statutory and regulatory requirements. Specifically, it applies to the manufacturing of primary packaging materials for medicinal products. This standard is based on ISO 9001, incorporating Good Manufacturing Practice (GMP) requirements relevant to primary packaging materials. The goal is to reduce risks associated with safety, quality, and regulatory compliance in the pharmaceutical packaging industry.
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