Comment from Jitendra Pund
AnonymousOpposeIndividual
Summary: The commenter argues that the proposed guidance is insufficient because it fails to specify which phases of clinical trials (Phase I or II) should be considered when investigating Out-of-Specification (OOS) results. They suggest that factors like improper storage of Active Pharmaceutical Ingredients (API) could lead to degradation and should be explicitly addressed in the guidelines.
Dear Sir/Madam,
The Out of Specification (OOS) result observed in the finished product may have occurred due to improper storage of the Active Pharmaceutical Ingredient (API) in the warehouse. If the API was not maintained under its recommended storage conditions—such as temperature, humidity, or protection from light—it could have degraded or lost potency. it is not covered in the guideline in which Phase (Phase I or II) it should be taken into account for investigation.