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Quality Control |
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| DEEF QUALITY CONTROL DEPARTMENT IS CONCERNED WITH: | Sampling and testing and with the organization, documentation, and release procedures which ensure that the relevant tests are actually carried out and that materials are not released for use, nor product released for sale or supply, until their quality has been judged to be satisfactory.
| | | | | Major objectives of QC includes but not limited to: | 1. Sampling, analysis and status changes of secondary, primary packaging materials, active and inactive raw materials.
| 2. Analysis of bulk and finished product samples.
| 3. Preparing the testing methods of packaging materials, raw materials, bulk and finished products.
| 4. Ensuring that the analysis "Chemical, physical and microbiological examination" are done according to the approved methods of analysis and all materials and products after completing the analysis are conforming to the predetermined specifications.
| 5. Environmental control of the processing, packaging and laboratories environment.
| 6. Implementation of installation qualification, operational qualification protocols of QC instruments, like HPLC, IR, UV-Visible spectrophotometer, Karl fisher Titrator, pH Meters, autoclave …… etc.
| 7. Development and validation of analytical methods according to the current ICH guidelines.
| 8. Contribution in the validation of manufacturing processes, instruments and machines.
| 9. Contribution in the cleaning validation studies.
| 10. Contribution in the validation of water system in the factory.
| 11. Execution of stability studies of products according to the current ICH guidelines and requirements of regulatory authorities.
| 12. Contribution in the qualification of suppliers.
| 13. Keeping and monitoring of reference samples from finished products and starting materials.
| 14. Contribution in the personnel qualification program.
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