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 | Dec 10, 2022 | Analytical Chemistry, Deviation, Documents error (DIN), Out of specification, Pharmaceutical interview,, QMS
DIN (documents incident) IncidentDeviationOOS DIN Documentary error like miss date and sign, entry missed in logbook, Incident Like power failure, peak shape not properly, baseline not properly et OOS Results was not found as per specification Share...