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Quality

Sustaining a culture of compliance.

Aragen’s robust quality systems across our various facilities ensure that customers can expect the same quality standards irrespective of location. While a quality leadership team with over 180 years of combined experience anchors our solutions, we firmly believe that quality is everyone’s responsibility. From senior management to the shop floor, we are all equally committed to delivering zero-defect products to customers, on time, and in full.

To meet the standards that our customers have come to expect from us, we:

  • Develop and implement internationally benchmarked quality management systems (QMS)
  • Employ people who commit to our quality culture
  • Invest in world class facilities
  • Focus on good documentation practices

Aragen has been audited and approved by leading regulatory agencies from around the world, including the USFDA, EDQM, ANVISA, PMDA and WHO. Our most recent audit with the USFDA was concluded with no observations. Regular audits (over 5 per month) by our growing list of customers, keeps us ‘audit ready’, and at the cutting edge of the latest developments in operating practices.

To ensure independent and impartial decision making, all our sites have their own quality teams that report directly to the global quality head and CEO. Corporate quality assurance (QA) focuses on developing and enforcing uniform standards across the organization on vendor management, quality control, electronic quality management system, digital initiatives (automation), management reviews, management information services, harmonization of procedures, quality compliance, training, turnaround time and quality by design.

At Aragen, we deliver products that enable our customers to make better health possible. What we do impacts lives, so as an organization, we are deeply committed to the quality, safety and effectiveness of our solutions.

Learn more about our end-to-end capabilities