by maheshbhuva | Jun 1, 2024 | Analytical Chemistry, Out of specification, Quality control (QC)
Scope Input Martial In process stage Finish product Stability Note : Not applied in process stage which give procedure Further operation (e.g like give option in BMR if result not found as per Limit and further go operation e.g CF drying sample) Purpose: Ensure that...
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 this: Click to...
