FDA · CV-REQ-000018

Monitor cleaning after validation

§ 12.7 — ongoing monitoringRevision 1

REGULATORY SOURCE · PARAPHRASED SUMMARY

What the source says

Monitor validated cleaning procedures at appropriate intervals during production.

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CLEAN VALIDATED INTERPRETATION · DRAFT

Connect it to your work

Give each monitoring trend an owner and a response rule.

AUDIT FOCUS · SUGGESTED QUESTION

Who reviews emerging trends?

RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE

A starting point for your review

  • Monitoring plan
  • trend review

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

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