EU GMP · CV-REQ-000001

Demonstrate sampling recovery

§ 10.12Revision 1

REGULATORY SOURCE · PARAPHRASED SUMMARY

What the source says

Recovery should be demonstrated for sampled contact materials and methods.

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CLEAN VALIDATED INTERPRETATION · DRAFT

Connect it to your work

Connect each material to the recovery study that supports its sampling procedure.

AUDIT FOCUS · SUGGESTED QUESTION

Which material–method combinations have supporting data?

RECOMMENDED PRACTICE · ILLUSTRATIVE EVIDENCE

A starting point for your review

  • Material inventory
  • recovery results
  • sampling procedure

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

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