FDA · CV-REQ-000017

Establish method capability

§ 12.7 — analytical methodsRevision 1

REGULATORY SOURCE · PARAPHRASED SUMMARY

What the source says

Analytical sensitivity and attainable recovery should support residue evaluation.

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CLEAN VALIDATED INTERPRETATION · DRAFT

Connect it to your work

Read the laboratory result together with the method capability statement.

AUDIT FOCUS · SUGGESTED QUESTION

Is a low result distinguishable from a method limitation?

RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE

A starting point for your review

  • Validation report
  • recovery data

These examples are editorial suggestions, not additional regulatory requirements. Applicability depends on your operation and the complete source.

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