Document Control (Metadata)

2. Purpose

Establish enforceable acceptance criteria governing storage and handling of materials to prevent contamination, deterioration, misidentification, status override, unauthorized use, and loss of traceability.

This specification defines objective control expectations and explicit entry triggers into controlled QMS processes. This specification defines entry criteria only and does not define workflow mechanics.

3. Regulatory Basis

• 21 CFR 111.70 — Specifications
• 21 CFR 111.80 — Quality control operations
• 21 CFR 111.105 — Quality control personnel responsibilities
• 21 CFR 111.113 — Material review and disposition
• 21 CFR 111.155–111.165 — Holding and distribution
• 21 CFR 111.605 — Record retention

4. Scope

Applies to all components, raw materials, in-process materials, packaging components, labels, retained samples, and finished goods stored within GMP-controlled areas under company control.

Excludes transportation activities after documented custody transfer to third-party carriers.

5. Definitions

• Compliant State: All defined acceptance criteria met and required records complete and traceable.
• Nonconforming State: One or more defined objective criteria not met.
• Invalid State: Required inspection or monitoring record missing, incomplete, illegible, or not traceable to a specific lot and location.
• Escalation Trigger: Objective condition requiring mandatory entry into a defined QMS process.
• Stop-Execution Condition: Immediate cessation of material movement, use, relabeling, or disposition until QU authorization is granted.

6. Acceptance Criteria

Execution may continue only when all attributes are in a Compliant State and required records are complete and traceable. Any Nonconforming or Invalid State prohibits execution continuation and requires mandatory QMS process entry.

7. Decision Logic Matrix

8. Exception Handling

• Any Nonconforming or Invalid State requires entry into the Deviation process.
• Confirmed contamination or identity compromise requires entry into the Quality Defect process.
• Recurring systemic failures require entry into the CAPA process.
• Modification of acceptance criteria requires Change Control approval prior to implementation.
• Final material disposition decisions remain under independent Quality Unit authority.

9. Required Records

• Material Condition Records
• Environmental Monitoring Logs
• Deviation Records (if triggered)
• Quality Defect Records (if triggered)
• CAPA Records (if triggered)
• Change Control Records (if triggered)
• QU Disposition Authorization Records

10. Authority Classification (E / W / A)

11. Control State Definitions

• Compliant State: Execution may continue.
• Nonconforming State: Execution stops for affected material; workflow entry required.
• Invalid State: Execution prohibited until resolved under Deviation process.
• Escalation Trigger: Integrity, identity, segregation, or environmental control failure.
• Stop-Execution Condition: Material movement, use, relabeling, or disposition is prohibited until QU authorization is granted.

12. Change Control

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

13. References

• QC-ENV-004 — Temperature-Controlled Storage Specification
• QC-REQ-IDX
• Deviation SOP
• Quality Defect SOP
• CAPA SOP
• Change Control SOP
• 21 CFR Part 111

14. Appendix A — Illustrative Use Case Scenarios (Informational Only)

The following scenarios represent common conditions that may trigger application of this specification. They are provided to promote consistent interpretation of defined control states.

These scenarios are representative examples only. Actual determination of control state, workflow entry, and authorization requirements shall be made exclusively through application of Sections 6 and 7.