FDA · CV-REQ-000016

Select suitable sampling methods

§ 12.7 — samplingRevision 1

REGULATORY SOURCE · PARAPHRASED SUMMARY

What the source says

Sampling should address soluble and insoluble residues appropriately.

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CLEAN VALIDATED INTERPRETATION · DRAFT

Connect it to your work

Match the sampling question to the residue and accessible surface.

AUDIT FOCUS · SUGGESTED QUESTION

Which residue types could be missed?

RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE

A starting point for your review

  • Residue assessment
  • sampling rationale

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

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