cGLP issues

1. Weight tape shall be attached & reviewed instantly and not be transferred to another area.
2. Any cross out/ trial injection shall be initialed and dated. To write “ Not used due to…….
3. Take near pH standard reading before every pH testing.
4. To know about job description.
5. Never discard any aliquot solution before analysis has been completed.
6. Ensure UV lamp of HPLC machine is off after analysis.
7. All not tested parameters to be mentioned as “Conforms”.
8. Change the water from sonicator before each RS sample preparation.
9. Clean all locker and drawer.
10. Rinsing bottle of Shimadzu HPLC machine to be refilled daily.
11. Used solvents/ reagents/mobile phase to be discarded by the analyst into the respective drum.
12. Discard HPLC vials immediately after the analysis has been completed.
13. Ensure sample set has been checked before injecting.
14. Sample shall be mixed thoroughly before each use.
15. Weight to be attached on the opposite of the worksheet.
16. Make entries in the retest log if necessary.
17. Volumetric solution shall be standardized before each assay test.
18. Take printout from dissolution tester.
19. Do not leave the balance without keeping it zero.
20. Ensure all time format shall be 24 hours.
21. Be confident and competent enough to demonstrate to the auditor about the procedure.
22. Keep mobile phone ringtone low.
23. Use individual ID for equipments operation/ documentation/ sampling & release in IMS.
24. Ensure manual integration has been “permitted and verified” by supervisor.
25. Sample trial injection shall be prohibited.
26. Use parafilm to close the mobile phase bottles.
27. Safety glasses must be worn during handling of reagents, chemicals.
28. Use spill kit if necessary.
29. Ensure your training has been completed on the current job (SOP/STP).
30. Do not feel shy to pick up any waste (tissue, paper etc) from floor or table since this is your home away from home.

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