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생명과학 eQMS 13개 항목

Combination Products cGMP Checklist (21 CFR Part 4)

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Confirms that a drug-device or biologic-device combination product operates under a compliant streamlined cGMP approach integrating drug (211) and device (820) requirements. Use to audit combination product manufacturing.

21 CFR Part 421 CFR 21121 CFR 820

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Constituent Parts and Approach

  • Are the constituent parts of the combination product identified and classified (drug, device, biologic)? *
  • Is a compliant cGMP operating model selected (drug or device base) with the streamlined approach documented? *
  • Are the applicable base regulation requirements fully met (e.g., 21 CFR 211 for drug-led operations)? *

Called-Out Device Provisions

  • Are the called-out device provisions implemented when operating under drug cGMP (design controls 820.30)? *
  • Is purchasing control (820.50) applied to device constituent suppliers? *
  • Are corrective and preventive action (820.100) requirements implemented? *
  • Is installation (820.170) and servicing (820.200) applied where relevant?

Called-Out Drug Provisions

  • When operating under device QMS, are the called-out drug provisions implemented (211.84 component testing, 211.166 stability)? *
  • Is expiration dating (211.137) applied to drug constituents?
  • Are reserve samples (211.170) maintained where required?

Integration and Reporting

  • Are interactions between constituent parts assessed for safety and performance? *
  • Are combination product adverse event and malfunction reporting requirements met? *
  • Are labeling and human factors considerations addressed for the integrated product?

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