Packaging Component Quality Acceptance Specification
This specification defines the Quality Unit–approved acceptance criteria and decision requirements governing the quality, suitability, and condition of packaging components prior to use in GMP packaging operations.
Authoritative Quality Control specification defining packaging component acceptance criteria and decision authority. This document does not define artwork approval, labeling procedures, or packaging line execution.
1. Purpose
To establish Quality Unit–approved requirements for evaluating packaging component quality and suitability, ensuring that packaging materials used in GMP operations do not compromise product identity, integrity, labeling accuracy, or regulatory compliance.
2. Scope
This specification applies to all primary and secondary packaging components, including containers, closures, labels, inserts, cartons, and related materials intended for use in GMP packaging operations.
Applicable Business Domains include:
- Packaging Operations (PKG)
- Quality Control (QC)
- Quality Assurance (QA)
- Warehouse Operations (WH)
- Supply Chain / Procurement
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-MAT-005
Packaging component acceptance criteria defined in this specification shall not be modified outside approved QMS change control.
4. Packaging Component Acceptance Criteria
| Attribute | Acceptance Criteria | Applicability |
|---|---|---|
| Component Identity | Packaging components shall match the approved specification, configuration, and version intended for use. | All packaging components |
| Physical Condition | Components shall be clean, intact, and free from damage, deformation, or contamination. | All packaging components |
| Labeling Accuracy | Labels, inserts, and printed components shall be correct, legible, and suitable for their intended product and market. | Printed packaging components |
| Compatibility & Suitability | Packaging components shall be compatible with the product and intended packaging process and shall not adversely impact product quality or stability. | Primary packaging components |
| Segregation & Status Control | Packaging components shall be appropriately segregated by status (e.g., quarantined, approved, rejected) to prevent mix-ups. | All packaging components |
Detailed specifications, artwork files, and version controls governing packaging components are maintained in approved product or packaging specifications. This specification governs acceptance authority only.
5. Decision Logic
- Packaging components meeting acceptance criteria are considered conforming for use.
- Packaging components exhibiting minor or isolated deficiencies require Quality Assurance review prior to use.
- Packaging components exhibiting incorrect identity, labeling errors, or significant damage shall not be used without Quality Unit approval.
- Final determinations regarding packaging component acceptance or rejection reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Incorrect or mismatched packaging components are identified
- Labeling errors or version discrepancies are detected
- Damage or contamination of packaging components is observed
- Recurring packaging component quality issues or trends are identified
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Packaging component inspection and acceptance records
- Artwork and version verification documentation
- Deviation and investigation records related to packaging components
- Quality Unit decisions regarding packaging component acceptance