The proof of quality printing is in the demanding standards that Gintzler International maintains. We support these principles by:

  • Achieving certification to ISO 13485:2016 standard to meet the stringent quality and service requirements of the medical and pharmaceutical industries
  • Earning GMI certification to demonstrate we have the required equipment and process controls to produce consistent packaging on a regular basis
  • Complying with cGMP guidelines to ensure quality for patient use of drug products
  • Conducting formal supplier evaluations in accordance with ISO standards
  • Selecting raw materials to meet our customers’ specifications, merchandising, quality and cost management
  • Providing a Benzophenone-free workplace and Benzophenone-free transit packaging, as directed
  • Maintaining a quality lab and test center for product analysis

Certified to ISO 13485:2016 Standard

ISO 13485 is an international quality standard that provides a foundation for a workable quality management system:

  • This certification aligns our management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world.
  • 13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire life-cycle, from initial concept to delivery and post-delivery.
  • Gintzler maintains these demanding standards to help customers achieve their corporate packaging goals related to brand protection and to thwart counterfeiting.
  • Our certification serves as a proven credential, as it is an independent verification against recognized standards.
  • Our management system closes the gap on regulatory changes—GS1, FDA and consumer protection.

ISO 13485:2016 certified label converter