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 | Jan 21, 2023 | 483 observation, Analytical Chemistry
The manufacturing practices of Indian drug makers have once again come under the scanner after the US Food and Drug Administration (USFDA) recently issued 11 observations to Intas Pharmaceuticals Limited over questionable practices at its manufacturing facility in...