by maheshbhuva | May 3, 2023 | 483 observation, Analytical Chemistry, Out of specification
Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab mean by At receiving lab At originating lab YES Required Caution: inform API vendor about failure Investigation release analysis Assess impact on DP(drug product)...
by maheshbhuva | Apr 9, 2023 | Deviation, Documents error (DIN), QMS
Why investigation? To identified error Random error Impacts precision (Weight error dilution error injection to injection error Example document error, document error [ note : Precision show random error which is not control for us] +- positive and negative error...
by maheshbhuva | Apr 5, 2023 | 621 USP CHAPTER, Analytical Chemistry
All chapter are use full for ADJUSTMENT of chromatography, TLC etc In such case some questions arias that Why adjustment in chromatography ? How adjustment justified ? Adjust chromatography If your method is validated and method are submitted in DMF so...
by maheshbhuva | Mar 16, 2023 | ALCOA++, Analytical Chemistry, QMS
Attributable Mainly to ask of following question is that Who, when, what and why? Who Person has identified When place has identified What event identified Why mean why all the operation will be happen that all example will give as on QMS activity document other...
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...