QRO Certification LLP


ISO 15378:2011 Certification

The ISO 15378 – Primary Packaging Materials for Medicinal standard was developed by stakeholders in the pharmaceutical sector to give a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products.

ISO 15378:2011 identifies needs 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 requirements and global standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS necessities applicable to primary packaging materials for medicinal products.

QRO Cert is an internationally acknowledged leader in certification for the pharmaceutical sector. The QRO Cert worldwide network of auditors understands you’re manufacturing procedures and the accurate meaning of all aspects of the standard. The ISO 15378:2006 standard includes a number of essential QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging.

Benefits of ISO 15378 Certification

  • Decrease of manufacturing errors
  • Additional assurance of quality products to your clients
  • Cost minimization for certified organization
  • Decrease in mistaken mix-ups
  • Enhancement in processes
  • Minimization or removal instances of contamination