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ISO 15378 Medicinal Standard

The ISO 15378 – Primary Packaging Materials for Medicinal standard was developed by stakeholders in the pharmaceutical sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products. When you certify your operation against the ISO 15378 standard, you mitigate your risks especially related to contamination, mix-ups and errors. Further, you ensure your customers of the compliance of your QMS. Qsek provides reliable, independent ISO 15378 certification for your pharmaceutical packaging materials manufacturing operation. During your audit prior to certification we analyze your operation, identifying strengths and outlining the areas where improvement is necessary.

Qsek is a globally recognized leader in certification for the pharmaceutical sector. The Qsek global network of auditors understand your manufacturing processes and the precise meaning of all aspects of the standard. The ISO 15378:2006 standard includes a number of important QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including:

Compliance to legal requirements

Identification, reduction and control of risks including contamination and manufacturing errors.Improved efficiency and cost-effectiveness in your operationPartner with Qsek when you need to demonstrate your ability to quality provide packaging materials for the pharmaceutical industry and help improve patient safety. Contact us today to learn more about ISO 15378 – Primary Packaging for Medicinal Products certification.