Supplier Qualification Status Impact Specification
This specification defines the Quality Unit–approved requirements governing how supplier qualification status impacts the acceptance, restriction, or use of components and raw materials in GMP operations.
Authoritative Quality Control specification defining supplier status impact and decision authority. This document does not define supplier qualification procedures, audit execution, or purchasing activities.
1. Purpose
To establish Quality Unit–approved decision rules defining how supplier qualification status influences material acceptance and usability, ensuring that materials sourced from suppliers are appropriate for their intended GMP use.
2. Scope
This specification applies to all suppliers providing components, raw materials, and packaging components intended for use in GMP manufacturing, packaging, or testing activities.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Supply Chain / Procurement
- Warehouse Operations (WH)
- Production (PROD)
- Packaging (PKG)
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-003
Supplier status impact rules defined in this specification shall not be modified outside approved QMS change control.
4. Supplier Status Definitions & Impact
| Supplier Status | Description | Impact on Material Use |
|---|---|---|
| Approved | Supplier has completed qualification and is maintained in good standing under the Quality Management System. | Materials may be accepted and used for GMP purposes, subject to meeting all applicable material acceptance criteria. |
| Conditionally Approved | Supplier qualification is limited, provisional, or subject to defined conditions or monitoring. | Materials may be accepted only under defined Quality Unit–approved conditions or restrictions. |
| Disqualified / Restricted | Supplier has failed qualification requirements or is subject to restrictions due to quality concerns. | Materials shall not be used for GMP purposes unless explicitly approved by the Quality Unit under documented exception. |
Supplier status alone does not override material-specific acceptance criteria. All materials must independently meet identity, purity, and suitability requirements prior to use.
5. Decision Logic
- Materials sourced from Approved suppliers may be considered for GMP use when all applicable acceptance criteria are met.
- Materials from Conditionally Approved suppliers require Quality Unit review prior to use.
- Materials from Disqualified or Restricted suppliers shall not be used for GMP operations without documented Quality Unit exception.
- Final determinations regarding supplier status impact and material usability reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Changes to supplier qualification status
- Quality concerns associated with supplier performance
- Receipt of materials from unapproved or restricted suppliers
- Requests for exception use of materials from restricted suppliers
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Supplier qualification and status records
- Material acceptance and restriction documentation
- Deviation, investigation, and exception approval records
- Quality Unit decisions regarding supplier-related material usability