483 observation

Key FDA Updates (Late May–Early June 2026)

The FDA’s latest updates (June 2026) include several new drug approvals, safety warnings on hidden ingredients in supplements, and upcoming…

1 month ago

QMS – CAPA MODULE

STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive…

2 months ago

OOS- Out of Specification Investigation – Interview Question and Answer

Do we need to raise an OOS, if OOS result is observed during API Method transfer First defined which lab…

3 years ago