What are the guidelines for OOS investigation?

Question

Accepted Answer

The guidelines for OOS investigation involve thorough documentation, root cause analysis, and corrective actions.

Thoroughly document all relevant information related to the OOS (Out of Specification) event.
Perform a comprehensive root cause analysis to identify the underlying reasons for the OOS.
Implement appropriate corrective actions to prevent recurrence of the OOS.
Follow established regulatory guidelines and industry best practices during the investigation.
Ensure proper communication and collaboration between different departments involved in the investigation.
Maintain a clear and transparent record of the investigation process and findings.

Accepted Answer

The objective of such an investigation should be to identify the root cause of the OOS result and take appropriate corrective and preventative action. investigation should include a review of production and sampling procedures, and will often include additional laboratory testing

What are the guidelines for OOS investigation?

Top Lupin Reviewer interview questions & answers