QC-MAT-001 — Component Identity Verification

Document Control (Metadata)

2. Purpose

Establish mandatory per-lot identity verification requirements for all incoming components prior to QU disposition for manufacturing use. This specification mitigates risk of misidentification, substitution, adulteration, and supplier fraud in accordance with 21 CFR 111.75(a)(1).

3. Regulatory Basis

• 21 CFR 111.70(b)
• 21 CFR 111.75(a)(1–3)
• 21 CFR 111.113
• 21 CFR 111.123(a)
• 21 CFR 111.605
• 21 CFR 111.610

4. Scope

Applies to all incoming component lots prior to QU disposition, including dietary and non-dietary components.

Excludes finished product identity testing, in-process verification, and analytical method validation governance.

5. Definitions

Identity Event: A documented analytical examination confirming component identity against an approved reference.

Orthogonal Method: A second analytical method based on a different scientific principle capable of discriminating non-identical materials.

Invalid State: Missing raw data, unapproved reference, instrument calibration lapse, undocumented execution, or inconclusive analytical output.

6. Acceptance Criteria

Compliant State: Identity confirmed per criteria above with complete raw data.

Nonconforming State: Confirmed mismatch to approved reference.

Invalid State: Missing/incomplete raw data, instrument out-of-calibration, correlation < 90%, or inconclusive output.

7. Decision Logic Matrix

8. Exception Handling

• Confirmed mismatch = Nonconformance.
• Missing raw data automatically invalidates the Identity Event.
• Supplier falsification triggers immediate CAPA.
• Changes to identity method, reference library, or thresholds require Change Control.

9. Required Records

• FTIR Spectral Match Report
• Raw Analytical Data
• Supplier Tier Classification Record
• Deviation / Quality Defect / CAPA Records (if triggered)
• QU Disposition Authorization

Records retained minimum 1 year past expiration or 2 years beyond distribution per 21 CFR 111.605.

10. Authority Classification (E / W / A)

• E: Sampling, testing, documentation.
• W: Entry into Deviation, Quality Defect, or CAPA processes.
• A: QU disposition approval and supplier reclassification.

11. Control State Definitions

Compliant: Meets all identity criteria with valid documentation.

Nonconforming: Confirmed mismatch.

Invalid: Incomplete, inconclusive, or noncompliant execution.

Escalation Trigger: Any Nonconforming or Invalid condition.

Stop-Execution: Manufacturing use prohibited until QU authorization.

12. Change Control

Changes to methodology, reference standards, thresholds, or tier logic require formal Change Control entry, documented impact assessment, and QU approval.

13. References

• QC-REQ-IDX
• QC-SPEC-STD-001
• CAPA SOP
• Quality Defect SOP
• Deviation SOP
• Change Control SOP
• 21 CFR Part 111