by maheshbhuva | May 18, 2023 | stability
The purpose of perform stability study is that establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests),...
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)...
