Which of the following is a criterion for further investigation of atypical laboratory results? Response:

Question

Options

• AResults are within trend but just outside of specification limits
• BAtypical results are confirmed and significantly impact product quality
• CAll atypical results, regardless of impact
• DOnly results that are favorable to the desired outcome Answer: B

Explanation

Option B is correct because regulatory guidance (e.g., FDA's OOS guidance and ICH Q10) requires further investigation when atypical (out-of-specification or out-of-trend) results are confirmed - meaning they survive the initial Phase I lab investigation - and have a meaningful impact on product quality, patient safety, or batch disposition decisions.

Option A is wrong because results within trend but just outside specification limits would typically trigger an out-of-specification (OOS) investigation anyway; framing them as "within trend" doesn't exempt them, and this option misrepresents the triggering criterion. Option C is wrong because not every atypical result warrants full-scale investigation - initial review may reveal an assignable root cause (e.g., analyst error, instrument malfunction) that invalidates the result without requiring further Phase II investigation. Option D is wrong because cherry-picking only favorable results is a form of data integrity violation and explicitly prohibited under GMP principles - investigations must be unbiased.

Memory tip: Think "Confirmed + Consequential = Continue investigating." Both conditions must be true - the result holds up under scrutiny and it actually matters to quality - before escalating to a full investigation.

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