The Company has undertaken to work under the aegis of Total Quality Management (TQM). In this connection, a Quality council has been formed with functional heads as council members.
The quality policy:
“WE SHALL PRODUCE AND DELIVER TO OUR CUSTOMERS PRODUCTS CONFIRMING TO CLEARLY ESTABLISHED REQUIREMENTS AND QUALITY PARAMETERS. WE COMMIT OURSELVES TO MAINTAIN THIS THROUGH A CULTURE OF QUALITY AWARENESS WITHIN THE ESTABLISHMENT BASED ON TRAINING AND DEVELOPMENT OF ALL THE MEMBERS OF THE ESTABLISHMENT. THE ESTABLISHMENT WILL FURTHER STRIVE TO UPGRADE QUALITY THROUGH IMPROVING ITS WORK PRACTICES AND PREVENTION OF DEVIATIONS.”
Quality Assurance is responsible for:
- Maintaining GMP at all stages of Production and Control
- Review of Production Records
- Review of Product Specifications and Test Procedures
- Release of Finished Goods
- Quality Audits
- Stability Studies
- Vendor Validations
- Product Compliances and Recall
- Validations & Qualifications
- Calibration
Rusan’s Quality Control has the most advanced instruments like Gas Chromatogram, High Pressure Liquid Chromatogram for screening & determining the impurity profiles of active ingredients as well as excepients. The efficacy, safety and quality of the product is ensured through a series of validations carried out upon manufacture and analysis. Each production batch is reviewed by Quality Assurance/Quality Control for completeness of manufacturing, analysis, Packing, In Process Quality Control (IPQC), Yields, deviations etc. prior to its release.