EU GMP · CV-REQ-000005

Use visual inspection within validation

§ 10.2Revision 1

REGULATORY SOURCE · PARAPHRASED SUMMARY

What the source says

A visual cleanliness check should form part of cleaning-validation acceptance criteria, but it is not generally acceptable as the sole criterion. Recleaning and retesting until residue results pass is not an acceptable validation approach.

Read the original passage ↗

CLEAN VALIDATED INTERPRETATION · DRAFT

Connect it to your work

Give visual findings a defined place in the acceptance decision.

AUDIT FOCUS · SUGGESTED QUESTION

How are visible residues recorded and investigated?

RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE

A starting point for your review

  • Inspection instruction
  • deviation record

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

Explore the topics

Related requirements