ISO 15378:2011 Primary Packaging Materials For Medicinal Products Certification

ISO 15378:2011 identifies necessities for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organizations require demonstrating their capability to constantly meet client necessities, including regulatory needs and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and identifies QMS needs applicable to primary packaging materials for medicinal products.

Obtaining this Standard confirms its ability to give primary packaging materials for medicinal products that constantly meet client needs. ISO 15378:2011 certification also identify the conditions for complying with International Standards applicable to primary packaging materials and Good Manufacturing Practice (GMP) guidelines for pharmaceutical product manufacturing.

ISO 15378:2011 is an application standard for the design, manufacture and provide of primary packaging materials for medicinal products. It is also applicable for certification reason.

Benefits of ISO 15378:2011

• Gain a competitive edge: by demonstrating the ISO 15378 compliance of your organization to all stakeholders with a trusted third-party certification partners.
• Minimize risk: by achieving documented compliance with security standards, thereby keep away from expensive liability.
• Save money and time: with a service supplier that eliminates the require for multiple assessments and get better productivity through process optimization.