The Quality Assurance department is controlling all aspects of manufacturing through the quality systems such as Product Certifications, complaint and recalls management, Self-Inspection and Internal Audits, and change control. For all these systems qualified individuals are organizing the quality meetings to assess the product releases/rejects, complaints and recalls, and changes in the production lines and procedures.
All GMP documents are reviewed, controlled, and approved by the quality Assurance department. Original copy of the master production records, SOP, data sheets and other forms related to production are archived in the quality assurance department. All the documentation revision dates are closely monitored and controlled by the qualified specialists in the quality assurance unit.
The supplier of the active ingredients and raw materials are qualified by the Quality Assurance Department. The Quality Assurance team conducts supplier audits and ensures that all materials are produced according to the GMP guidelines and procedures.
In addition, the quality assurance department approves all Drug Master Formulations (DMFs). For any new products, these documents will be submitted to the ministry of health for approvals. All GMP related issues such as compliant, recalls, and adverse effects will be communicated to the ministry of health for further analysis and investigations.