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Retain and Reserve Samples Checklist (21 CFR 211.170)

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Confirms that reserve (reference) samples of active ingredients and finished products are collected, stored, and retained in the required quantities and durations to support investigations. Use to audit the retain sample program.

21 CFR 211.17021 CFR 211.180EU GMP Annex 19

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Sample Collection

  • Are reserve samples collected for each active ingredient lot and each finished product batch? *
  • Is at least twice the quantity necessary for all release tests (excluding sterility and pyrogen) retained? *
  • Are finished product reserve samples retained in the marketed container closure system or an equivalent? *
  • Are samples representative and identified with batch/lot traceability? *

Storage Conditions

  • Are reserve samples stored under the same labeled storage conditions as the marketed product? *
  • Are storage areas secure, access-controlled, and monitored for temperature/humidity? *
  • Is sample inventory reconciled and tracked? *

Retention Periods

  • Are finished product reserve samples retained for at least 1 year past the expiration date? *
  • Are active ingredient reserve samples retained for the required period (1 year past finished product expiry or 3 years after distribution)? *
  • Are retention periods for OTC drugs without expiration dates set to 3 years after distribution?

Examination and Use

  • Are reserve samples visually examined at least once a year for evidence of deterioration? *
  • Are examination results recorded and any deterioration investigated? *
  • Are samples made available to support complaints, recalls, and investigations? *

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