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Different between method validation ICH & ANVISA

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,...

How can read Protocol analyst wet lab or Chemical analysis

by maheshbhuva | Feb 11, 2023 | Analytical Chemistry, GMP

â—‹ Whenever supervisor give work allocation for testing any product.â—‹ Then careful read specification(SOP) not missing any point which is defied in sopâ—‹ Before start analysis glassware collect in try â—‹ Labelling of each glassware â—‹ Seen availability chemicals and...

Analyst do some most common error ? How care and prevent QMS activity

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...

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