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ISO 15378:2017 is an international standard that specifies requirements for the design, development, and production of primary packaging materials for medicinal products.
» Applicability: ISO 15378:2017 applies to manufacturers of primary packaging
materials, such as
containers, closures, and other packaging components, used for medicinal products.
» Purpose: The primary purpose of ISO 15378:2017 is to establish a framework
for ensuring the
quality, safety, and traceability of primary packaging materials to meet .
Quality Assurance: ISO 15378 helps ensure that primary packaging materials are produced and maintained under strict quality control measures. This contributes to the overall quality and safety of pharmaceutical products.
» Regulatory Compliance:Global Acceptance: Compliance with ISO 15378 is recognized and accepted globally, facilitating market access for pharmaceutical products in various regions.
» Efficient Supply Chain Management:Streamlined Procurement: Pharmaceutical manufacturers can confidently source primary packaging materials from suppliers
» Cost Reduction:Reduced Product Rejections: Compliance with ISO 15378 can lead to fewer product rejections or recalls due to packaging-related issues, saving costs associated with product replacement, disposal, and regulatory penalties.
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