Q1. What is the inspector’s aim at first?
A. Inspectors usually start with systems and records. They investigate whether the site has control over data and quality.
Q2. Will CAPAs fail?
A. Yes. CAPAs do fail because the root cause was not correctly identified or the fix did not address the real problem.
Q3. Can we improve inspection-readiness?
A. Yes, we can improve inspection-readiness. It is possible if we keep documents current, train teams, quickly close the gaps, and test the system through mock reviews.
Q4. Are the Authorities – FDA, EMA, and DCGI – expecting the same?
A. Their core principles look similar. The focus and wording can differ. It mandates that organizations adhere to local regulatory requirements.
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