Quality & Standards | Gintzler International Pharmaceutical

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

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