Quality Assurance

If there is one core attribute to which we attach the highest priority, and on which we will not compromise, it is quality. Read about our global quality standards here.

OUR QUALITY VISION

Our vision is to globalize, harmonize and simplify GxP processes to ensure asustainable quality culture. At AZURE, we work towards continuous improvement of our Quality Management System (QMS) and all its elements.We are building and maintaining a strong culture of quality through the on-going development, training, and empowerment of our personnel. We believe that producing safe, high-quality product is everyone’s responsibility.

To maintain the quality assurance of products we offer we look and control everthing realted to the making of the product like.
  • Harmonization of Compliance Processes
  • Lessons Learned” Strategy
  • Global Quality Metrics
  • Quality by Design Principles (QbD) for Sustainable Quality
  • Quality Data Governance

We have established global level documentation structure to ensure harmonized processes, methods and strategies throughout the organization. This concept enables planning monitoring, and facilitating continuous improvement of product quality supporting regulatory compliance.

Lessons Learned” strategy is an integral part of our quality culture. The process includes identification of gaps, their analysis, risk mitigation and taking corrective actions. This approach not only addresses the issues but leads to actions to prevent similar occurrences in the future, and at the same time identifies what went well and how similar processes may benefit from this information.

The global quality metrics represent a selection of statistical analysis which have been agreed to at a global level. As part of innovation and continuous improvement, the selected quality indicators are monitored, measured and analysed on a routine basis.

We basic concept of QbD is that “Quality cannot be tested into the product, but it should be built into it”. We are implementing a “21st Century Quality Initiative” across the organization including R&D,technical and quality operations to perform quality, risk and knowledge management assessments.

We are investing in electronic applications, enabling the organization to establish harmonized processes through automation, develop site level metrics and indicators, and to put analysis and risk indication abilities to a new level of execution and control