QC-DISP-001 — Lot Disposition Authority

2. Purpose

This specification establishes the exclusive, non-delegable authority and enforceable decision criteria governing GMP lot disposition. It mitigates regulatory risk associated with unauthorized release, improper rejection, uncontrolled reprocessing, and distribution of nonconforming product under 21 CFR Part 111.

3. Regulatory Basis

21 CFR 111.103 — Quality control operations
21 CFR 111.113 — Material review and disposition decision
21 CFR 111.123 — Approval and release for distribution
21 CFR 111.127 — Reprocessing
21 CFR 111.140 — Review of batch production records
21 CFR 111.605 — Record retention

5. Definitions

Disposition: Final documented quality decision assigning lot status.
Compliant State: All required QC-REQ criteria met; no unresolved quality-impacting event.
Nonconforming State: One or more acceptance criteria not met.
Invalid State: Required QC data, review, or authorization missing.
Stop-Execution Condition: Distribution prohibited pending QU authorization.

6. Acceptance Criteria

Attribute	Objective Requirement	Compliant Condition	Nonconforming Condition	Invalid Condition	Escalation Trigger	Required QMS Entry	Authorization Gate
QC Testing	100% required QC-REQ tests completed	All results within approved specification limits	Any OOS / OOT result	Missing or unsigned test record	OOS, OOT, conflicting data	Deviation	QU Disposition Authorization
Batch Record Review	Complete review performed	No unresolved quality-impacting deviation	Unresolved critical deviation	Incomplete review	Deviation affecting identity/purity/strength/composition	Deviation	QU Disposition Authorization
Quality Events	No open critical event	All deviations closed or QU-approved for disposition	Open event impacting lot suitability	No documented event review	Confirmed defect or systemic issue	Quality Defect or CAPA	QU Disposition Authorization
Rework/Reprocess	Pre-approved under controlled change	Approved change control in place	Unapproved rework attempt	No change documentation	Process modification affecting quality	Change Control	QU Approval Required

Execution Continuation Condition: Lots may remain in Quarantine or Hold status pending QU disposition. No lot may advance to Release status without QU authorization. Manufacturing operations may continue on unrelated lots provided no systemic or cross-lot impact has been identified within a deviation or CAPA workflow.

7. Decision Logic Matrix

State Classification	Trigger Condition	Required Action	QMS Process Entry	Workflow (W)?	QU Authorization (A)?	Required Record
Compliant State	All acceptance criteria met	Approve Release	None	No	Yes	Lot Disposition Authorization Record
Nonconforming State	Any OOS, unresolved deviation, or failed criterion	Initiate Deviation	Deviation	Yes	Yes (for final disposition)	Deviation Record + Final Disposition Record
Invalid State	Missing QC data or incomplete review	Invalidate Disposition Attempt	Deviation	Yes	No	Deviation Record
Reassessment Trigger	Post-release signal including complaint trend, stability OOS, adverse event linkage, regulatory inquiry, or recall signal	Reopen Lot Evaluation	Quality Defect	Yes	Yes	Defect Record + Reassessment Decision Record

8. Exception Handling

The following constitute mandatory workflow entry triggers:

Out-of-specification result
Out-of-trend result
Data integrity anomaly
Unapproved reprocessing
Confirmed product defect
Repeat deviation indicating systemic failure

CAPA entry is required when systemic recurrence or cross-lot impact is identified within a deviation investigation.
Change Control entry is required for specification modification or process change affecting quality.
Final lot disposition cannot occur without QU authorization.

9. Required Records

Lot Disposition Authorization Record (QU signed)
Batch Production Record (Reviewed)
QC Laboratory Records
Deviation Record (if triggered)
CAPA Record (if triggered)
Quality Defect Record (if triggered)
Change Control Record (if triggered)

Records must meet 21 CFR 111.605 retention requirements.

10. Authority Classification (E / W / A)

E — Execution: QC testing, batch review documentation, record compilation.
W — Workflow: Deviation, CAPA, Quality Defect, or Change Control entry when triggered.
A — Authorization: Final lot disposition decision is non-delegable Quality Unit authority.

Execution does not confer authority to release, reject, reprocess, or destroy product.
Execution may continue without workflow entry only when all acceptance criteria remain in Compliant State and no escalation trigger condition exists.

11. Control State Definitions

Compliant State: All criteria satisfied; QU-signed release recorded.
Nonconforming State: One or more criteria failed; deviation workflow active.
Invalid State: Disposition attempt without required data or authorization.
Escalation Trigger: Any condition listed in Section 8.
Stop-Execution Condition: Distribution blocked until QU authorization documented.

Document ID	QC-DISP-001
Title	Lot Disposition Authority
Document Type	Authoritative QC Specification
Owner	Quality Unit (QU)
Approver	Quality Unit (QU)
Effective Date	TBD
Version	v1.0
Change Control Reference	CC-_____