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Drug Research Centre Quality Control /Quality Assurance System is well-established ,accurate and precise through: -Application of DRC- SOPs.
-High traceability system.
-Sharp and accurate documentation through control files and control documents.
-Highly qualified, extensive on job training personnel.
Quality Control Policy 1.Inspection: Every action should be controlled and observed visually. Inspectors should be provided with Check List of unacceptable Non-Conformity. 2.Re-Evaluation: Re-evaluation with modification, if required, of DRC Quality Control/ Quality Assurance system according to updated Specifications / Regulations in order to obtain Top quality. 3.Documentation: All procedures applied by DRC staff should be accurately and precisely documented in it's specified Notebook, Logbook…etc according to the applied SOP's with complete related details to ensure perfect traceability. 4. In Research Management: Quality control system should ensure inspection of both investigators and working team performance throughout the study (Research) according to SOP's in order to ensure its alignment with the scope.
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DRC Quality Control Unit assure the completeness,accuracy and adequacy of the procedures and contents of Bioequivalence, Biowaiver, Expert reports and all research activities.
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Quality Control Handling of Drug Samples
- Drug Samples are received, handled and kept in secure and access control place, as per approved Standard Operating Procedures (SOPs).
- Each Drug sample is given a unique DRC Code as per approved SOPs.
- Unused or remained Drug Samples kept in secure and access control place according to approved SOPs.