Component Identity Verification Specification
This specification defines the Quality Unit–approved identity verification acceptance criteria and decision requirements for components and raw materials prior to use in GMP manufacturing operations.
Authoritative Quality Control specification defining identity verification acceptance criteria and decision authority. This document does not define sampling procedures, test methods, laboratory execution instructions, or analytical methodologies.
1. Purpose
To establish Quality Unit–approved requirements for verification of component and raw material identity, ensuring that materials used in GMP operations are confirmed to be what they are represented to be prior to use.
2. Scope
This specification applies to all components and raw materials intended for use in GMP manufacturing, packaging, or testing activities, including active ingredients, excipients, processing aids, and packaging components where identity verification is required.
The required rigor of identity verification is determined based on material classification, complexity, and risk, as defined in the Quality Control– approved Identity Verification Strategy & Material Classification (QC-ID-STRAT-001).
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Material Readiness (MR)
- 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-001
Identity verification acceptance criteria and decision requirements defined in this specification shall not be modified outside approved QMS change control.
4. Identity Verification Requirements
| Material Type | Identity Verification Requirement | Applicability |
|---|---|---|
| Active Ingredients | Positive identity verification demonstrating conformance to the approved material specification | Each lot prior to GMP use, unless an approved reduced or skip-lot verification approach is justified and authorized in accordance with QC-SAMP-004 |
| Excipients & Processing Aids | Identity verification sufficient to confirm material identity and prevent mix-ups or substitution | Each lot prior to GMP use, unless otherwise justified, approved, and governed under QC-SAMP-004 |
| Packaging Components | Identity verification sufficient to confirm correct component, configuration, and suitability for intended use | Prior to use in GMP packaging operations, per approved sampling plans |
Identity verification may be performed using one or more Quality Unit–approved approaches, including analytical testing, validated supplier programs, or other scientifically justified methods. The adequacy of the approach, including any application of reduced or skip-lot verification, is determined and approved by the Quality Unit.
5. Decision Logic
- Materials that meet identity verification requirements are considered conforming for identity.
- Materials failing identity verification shall not be used in GMP operations.
- Questionable, inconclusive, or conflicting identity results require documented assessment and escalation to Quality Control.
- Only the Quality Unit may approve identity acceptance, rejection, or conditional disposition.
6. Escalation Requirements
Quality Assurance shall escalate to Quality Control or QCO when any of the following occur:
- Failure to verify material identity
- Discrepancies between supplier documentation and verification results
- Suspected material mix-ups, mislabeling, or substitution
- Recurring identity verification failures or adverse trends
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Identity verification test records or documented assessments
- Supplier documentation supporting identity confirmation
- Deviation, investigation, and quality event records related to identity failures
- Quality Unit decisions regarding material identity acceptance or rejection