Quality
Where Quality Meets Innovation
Our vision is to globalize, harmonize and simplify GxP processes to ensure a sustainable quality culture. At Shaimil, we have established Quality Management System (QMS) and all its elements and work towards continuous improvement. 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.
- Quality Management System
- Harmonization of Compliance Processes
- “Lessons Learned” Strategy
- Quality Metrics
- Quality by Design Principles (QbD) for Sustainable Quality
- Quality Data Governance
How it works
Quality
Quality Management System
We follow quality standard at Shaimil. We ensure its implementation across different functions, including research & development, technical operations, packing and supply chain. The Quality Manual covers all the quality system elements of the QMS as they are applicable throughout our lines of business. We use the best practices to ensure consistent, high-quality products are delivered to the patients.
Harmonization of Compliance Processes
We have established 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
“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.
Quality Metrics
The 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 analyses on a routine basis
Quality by Design Principles (QbD) for Sustainable Quality
The 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.
Quality Data Governance
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.