FDA · CV-REQ-000010

Understand swab compatibility

§ Direct surface samplingRevision 1

REGULATORY SOURCE · PARAPHRASED SUMMARY

What the source says

Sampling materials and extraction solvents can influence analytical results.

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CLEAN VALIDATED INTERPRETATION · DRAFT

Connect it to your work

Include the consumables used on site in the study design.

AUDIT FOCUS · SUGGESTED QUESTION

Are the study swabs the same as routine swabs?

RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE

A starting point for your review

  • Consumable specification
  • blank results

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

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