Written question
What action should be taken if a sample fails to meet the acceptance criteria during a Hold Time Study?
Show model answer and explanation
Answer
The result should be handled according to the applicable OOS, deviation, or investigation procedure. The cause and impact should be assessed, and the proposed holding time should be reconsidered based on the investigation and available scientific evidence. The limit should not be approved without adequate justification.
Explanation
Mention investigation, impact assessment, and evidence-based decision-making.