Document Control (Metadata)

Field Value
Document IDQC-DISP-003
Versionv1.0
StatusImplemented
Effective Date03/01/2026
Function OwnerQuality Unit (QU)
Approved ByQuality Unit Director
Controlled System of RecordGitHub
Change ControlQMS-1354
Last Review Due03/01/2026
Next Review Due03/01/2027

Rejection & Quarantine Governance Specification

2. Purpose

Establish enforceable governance requirements for identification, segregation, status control, and disposition authorization of rejected, quarantined, or held GMP materials to mitigate regulatory exposure under 21 CFR Part 111 and prevent unauthorized use, distribution, mix-up, or loss of traceability.

3. Regulatory Basis (CFR Anchors)

4. Scope

Applicability: All GMP-designated components, packaging materials, labels, in-process materials, finished goods, returned goods, retained samples, and any material subject to Quality status control.

Exclusions: This specification does not define procedural workflow mechanics for CAPA, Deviation, Quality Defect, or Change Control processes.

5. Definitions

Invalid State: Status identification, system control, segregation, or traceability condition is missing, conflicting, or unverifiable.

System Status Block: Electronic restriction preventing allocation, picking, or release.

Traceable Record Linkage: Documented reference connecting material to originating lot and associated quality record.

6. Acceptance Criteria

6.1 Compliant State (Execution Permitted)

- Physical status identification present and legible - Electronic system status aligned with physical status - System status block active - Segregation maintained - Traceable record linkage present Execution may continue within defined status limitations.

6.2 Nonconforming State (Workflow Mandatory)

- Unauthorized movement - Unauthorized status override - Use, staging, or allocation contrary to assigned status Deviation entry required unless product impact is confirmed, in which case Quality Defect entry required.

6.3 Invalid State (Stop-Execution Mandatory)

- Missing status identification - Conflicting physical and electronic status - Inactive system block for restricted material - Missing traceability documentation Execution must stop immediately for affected material. Deviation entry required.

6.4 Escalation Trigger (CAPA Mandatory)

- Two or more status control failures within a rolling 90-day period - Confirmed unauthorized use of restricted material - Confirmed distribution of restricted material CAPA entry required.

6.5 Invalid Record Condition

A control execution record is invalid if status documentation, system alignment, or traceability reference is absent, incomplete, or conflicting.

6.6 Reassessment Trigger

Any change in material condition, impact determination, or newly identified information requires reassessment under this specification.

6.7 QU Authorization Gate

Status removal, disposition decision (Release, Reject, Rework, Destroy), and release of previously restricted material require documented QU authorization.

7. Decision Logic Matrix

Trigger Condition Execution May Continue? Required Action QMS Process Entry Workflow (W)? QU Authorization (A)? Required Record
Compliant State Yes Maintain segregation and record verification No No No Control Execution Record
Invalid State No Stop execution and segregate material Deviation Yes Yes (if disposition impacted) Deviation Record
Unauthorized movement (no product impact) No Contain material and initiate deviation Deviation Yes Yes Deviation Record
Confirmed product impact or distribution No Contain material and initiate defect process Quality Defect Yes Yes Quality Defect Record
Escalation Trigger Met (Section 6.4) Yes (unaffected material only) Enter CAPA process CAPA Yes Yes CAPA Record

8. Exception Handling

Nonconforming or invalid state conditions require entry into Deviation or Quality Defect processes as defined in Section 6.
Escalation triggers require CAPA entry.
Specification modification requires Change Control entry.
Disposition actions require QU authorization.

9. Required Records

10. Authority Classification (E / W / A)

E: Status identification, segregation, and verification activities.
W: Mandatory QMS workflow entry when defined trigger conditions occur.
A: Disposition approval, status removal, and release authorization under independent Quality Unit authority.

11. Control State Definitions

Compliant State: All required physical, electronic, and documentation controls aligned and verifiable.

Nonconforming State: Status control breach requiring mandatory QMS workflow entry.

Invalid State: Missing, conflicting, or unverifiable control condition requiring stop-execution.

Stop-Execution Condition: Any invalid state or unauthorized movement of restricted material.

Escalation Trigger: Objective threshold defined in Section 6.4 requiring CAPA entry.

Record Invalid Condition: Missing or conflicting control execution documentation.

Reassessment Trigger: Any change in material condition or impact determination requiring re-evaluation.

12. Change Control

Changes to this specification require formal Change Control entry, documented impact assessment, and Quality Unit approval.

13. References

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