Manufacturing and quality

Analytical procedures and OOS investigations

Q14 addresses analytical development and maintenance; Q2(R2) addresses validation. An OOS result needs scientific investigation; unjustified retesting does not resolve the original result.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: Distinguish method suitability from investigation of the sample or process.

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Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Define the method purpose, range and performance criteria.
Retain original data and the complete analytical sequence.
Record investigation hypotheses and supporting or conflicting evidence.
Justify retesting, escalation and quality-unit review.

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Analytical procedures and OOS investigations

Prepare your evidence before a decision

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