Quality assurance can be defined as “part of quality management focused on providing confidence that quality requirements will be fulfilled.” The confidence provided by quality assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties. An alternate definition is “all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality.”

  1. QUALITY ASSURANCE  authority and responsibility of assessing and ensuring that all the products manufactured at site as per regulatory requirement.
  2. To monitor the entire manufacturing and quality control activities and to notify the management of any significant variation from the company standards which potentially affect the product quality.
  3. To ensure for each product there is an annual product quality review covering manufacturing activities, in order to provide assurance that product confirms to customers and regulatory requirements.
  4. To establish that manufacturing activities including any proposed changes are in accordance with regulatory requirement.
  5. Any changes which affect compliance with product standard should be approved by Head Quality Assurance before they are implemented.
  6. To review, suggest and ensure that plant is in validated state and confirms to regulatory requirements.
  7. Responsible for ensure the compliance of cGMP practices at all stages of production and control.
  8. Review of master documents and its control
  9. Review of production records and in process controls.
  10. Review of product specifications and test procedures.
  11. Responsible for Release/Reject of Finished Goods.
  12. Quality audits and quality manual
  13. Review of Stability studies
  14. Vendor Qualifications
  15. Training program
  16. Deviation and failure investigation
  17. Change control management
  18. Product complaints and recall
  19. Validations and Qualifications
  20. Calibration program
  21. Returned goods and their disposal
  22. Monitoring of Plant preventive maintenance