by maheshbhuva | Feb 26, 2023 | Method validation
FORCED DEGRADATION: ICH: a2R1) VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY ANVISA: CoLLEGIATE BOARD RESOLUTION – RDC No. 53, OF DECEMBER 4, 2015 Topic: metal ion catalysed oxidation ICHNOT required ANVISARequired analysis cu 2+, Fe 3+(accelerate,...
by maheshbhuva | Feb 11, 2023 | Analytical Chemistry, GMP
○ Whenever supervisor give work allocation for testing any product.○ Then careful read specification(SOP) not missing any point which is defied in sop○ Before start analysis glassware collect in try ○ Labelling of each glassware ○ Seen availability chemicals and...
by maheshbhuva | Feb 6, 2023 | Analytical Chemistry, Deviation, Documents error (DIN), Pharmaceutical interview,, QMS
Wet Lab analyst do Error ! Wet lab analyst are forgot a taken out of LOD or sulphated Ash, weight forgotten, etc ! . Some dilution error !. Weight print are not past in work sheet OR analytical work report or protocol etc (whatever terminology used). ! Calibration...