The quality assurance system at Sobhan Darou Company is comprehensively designed and implemented covering all matters which individually or collectively may influence the quality of a product, ensuring that the medicinal production has the quality required for its intended use.
Quality Assurance program is based on an integrated documentation system of specifications,Standard Operating Procedures and Batch Production Records, all working under the supervision of responsible pharmacist, supported by qualified equipment, processes and trained personnel.
The company dynamically works with improvement of its quality including its policy of ethics, stating that the production may not cause any serious hazard to employees or the environment, and reasonable and professional documentation.
The responsibility of quality function is by the responsible pharmacist to control, optimize and improve quality in the company.
Quality control department is separated from the production department, and is responsible for regular control of all incoming materials, finished products, in-process control, analysis, authorization of specification and stability tests.
Quality Assurance System should validate the total documentation for final release of all products before any distribution and approve that all have been in accordance with GMP and ISO-9001:2008 standards plus the specific requirements from the Ministry of Health.
All internal audits, external audits, calibration of equipment are controlled by Quality Assurance System The results are reviewed according to SOPs of Management Review to demonstrate the adequacy of the quality system.
The company uses ISO-9001:2008 standards to assess its suppliers. Suppliers of starting materials are validated for quality and reliability
Main structure of quality control of all products
Product specification, including:
Raw material, packing material, analytical claims and method (monographs) ,etc
Monographs, analytical methods, records of all analysis complied with specifications, etc
All specifications, masters and SOPs, have to be authorized by production manager as well as quality manager
The Quality Assurance function is responsible for:
Monitoring and implementation of QA policy Ensuring compliance to GMP and ISO-9001 equirements throughout the plant Monitoring and controlling quality of inputs and products at various stages Review of In-process test results, Finished product test results and release of product for distribution Maintain and update all documents in accordance with statutory/regulatory requirements Ensure compliance to regulatory requirements on product, process and release procedures Conduct and evaluate training for personnel Self inspection of facility and plant operation Evaluate quality of finished products Market complaint evaluation Wastage control Real time stability studies.