Quality Control and Assurance
The Quality unit at Star Laboratories is consisting of Quality Assurance (QA) and Quality Control (QC), which are working independently.
Quality Assurance is a wide range of concept which covers all matters individually or collectively influencing the quality of a product. It is the aggregate of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practices plus other factors relevant to quality and confirming the consistency of quality improvement at site.
At Star Laboratories, the system of Quality Assurance appropriate for the manufacture of medicinal products ensure that:
- Products are designed and developed according to requirements of GxP.
- Production and control operations are clearly specified and GMP adopted.
- All necessary controls on starting materials, intermediate and finished products are carried out.
- Effectiveness and applicability of Quality Management System (QMS).
The main tasks and duties of Quality Control have been described and is responsible for testing and analysis. Head of Quality or his delegates are responsible for releasing of drug substances, excipients, dosage forms and packaging materials. Laboratories are fully equipped with high-tech machineries which are able to handle effectively following forms:
- Liquid and Dry Suspension.