Program: QC-LAB Program Oversight
Owner: Quality Assurance (QA)
Authority: Quality Control Officer (QCO)
Version: 1.0
Last Updated: 2026-01-23

QC-LAB Program Oversight

Program-Level Oversight Notice
This document defines governance, monitoring, and escalation expectations for laboratory data used in quality decision-making. It does not define laboratory test methods, execution instructions, or acceptance criteria. All laboratory rules and specifications remain governed under QC Rules. Final quality disposition authority resides with the QCO.

1. Purpose

The QC-LAB Program establishes Quality Assurance oversight for all laboratory data used to support quality decisions, including data generated by external accredited laboratories and limited internal analytical support activities. The program ensures that laboratory data are reliable, traceable, scientifically valid, and suitable for use in quality disposition.

2. Scope

This program applies to all laboratory data used in support of product release, investigations, complaints, deviations, CAPA, and quality trending activities, including:

External ISO/IEC 17025–accredited testing laboratories
Third-party microbiological, chemical, and potency testing
Internal analytical support activities (e.g., FTIR identity screening, bench checks)
Laboratory data used for release, conditional release, rejection, or escalation

This program does not govern laboratory execution procedures, test methods, or acceptance limits.

3. Program Ownership & Authority

Role	Oversight Responsibility
QA	Owns the QC-LAB Program; monitors laboratory data integrity, performance trends, and escalation signals; executes QA WINs in response to program findings.
QCO	Sole authority for laboratory-based quality disposition decisions, including release, rejection, conditional acceptance, and escalation.
External Laboratories	Generate analytical results in accordance with approved methods, accreditation requirements, and Quality Technical Agreements.

4. External Laboratory Oversight

QA maintains oversight of all external laboratories providing data used for quality decisions. Oversight includes:

Laboratory qualification and approval status
Accreditation validity (ISO/IEC 17025 or equivalent)
Quality Technical Agreement (QTA) compliance
Data integrity and traceability
Retest behavior and result consistency

Trends or anomalies identified under this program trigger QA execution actions via applicable QA WINs.

5. Internal Analytical Support Oversight

Internal analytical activities are limited to defined support functions and do not constitute independent disposition authority. Oversight ensures:

Internal tools (e.g., FTIR) are used only within their approved scope
Results are classified as screening, supportive, or investigative
Limitations of internal methods are clearly understood
Results are not used as sole release evidence unless explicitly authorized

Internal analytical results that conflict with expectations or external data must be escalated through QA WINs for QCO review.

6. Program Monitoring & Signals

Monitoring Signal	Program Concern	QA Response
Repeated OOS / OOT results	Laboratory performance or method reliability	Trigger QA deviation or CAPA WIN
Conflicting lab results	Data credibility risk	Trigger QA release or investigation WIN
High retest frequency	Potential data manipulation or instability	Escalate to QCO via QA WIN
Internal screening mismatch	Material identity or quality concern	Escalate for external confirmation

7. Relationship to QA WINs

The QC-LAB Program does not execute corrective actions directly. Identified signals initiate QA execution through approved WINs, including:

WIN-QA-RELEASE
WIN-QA-DEVIATION
WIN-QA-CAPA
WIN-QA-CHANGE
WIN-QA-COMPLAINT

QA executes evidence review and escalation. The QCO renders final decisions.

8. Management Review & Continuous Improvement

QC-LAB Program performance is reviewed during Management Review and Annual Product Quality Review (APQR). Program outputs support:

Laboratory performance evaluation
Supplier and lab qualification decisions
Risk identification and mitigation
Systemic improvement initiatives

Authority Reminder
This program provides governance and oversight only. Laboratory execution rules, QA execution activities, and quality disposition authority remain governed by their respective architectural layers.