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 6, 2023 | 621 USP CHAPTER
Adjustment of Mobile Phase Adjustment in composition of the mobile phase Adjustment ph of the aqueous component of the mobile phase Adjustment in concentration of salts in the buffer component of a mobile phase Adjustment in composition of the mobile phase Minor...
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 24, 2023 | Hplc
HPLC Calibration we have perform as earlier as per protocol Company will provided Like example Shimanzu HPLC calibration will perform as per that guidance’s But now a day In 16th September 2021 As per IPC Pharmacopeia give guidance(Document ID IPC/GD/05) HPLC...
