Document ID: WIN-QA-STABILITY-EG
Version: 1.0
Last Updated: 2026-01-23
WIN Execution Guide — Stability Program Oversight
Non-Authoritative Execution Guide Notice
This WIN Execution Guide is non-authoritative and supports execution of controls
defined in the QA Family Pack. Authority for stability requirements, acceptance
criteria, approval, and change control resides solely with the QA Family Pack
and the Quality Management System (QMS).
Purpose
To support consistent QA oversight of stability activities by ensuring stability
programs are authorized, executed, documented, and reviewed in alignment with
approved protocols and regulatory expectations.
Scope
This WIN Execution Guide applies to QA-supported stability oversight activities
for finished products and intermediates subject to stability monitoring.
- Verification of approved stability protocols
- Confirmation of sample identity and storage conditions
- Review of stability testing documentation and data packages
- Escalation of stability excursions or failures
- Support for quality disposition and shelf-life decisions
This Execution Guide does not define stability study design, test methods,
acceptance criteria, or statistical analysis. Those requirements are governed by
QC rules, validated methods, and approved stability protocols.
Decision Authority
The Quality Control Officer (QCO) is the sole authority for:
- Approval of stability protocol adequacy
- Acceptance or rejection of stability results
- Approval of shelf-life assignment or extension
- Escalation to investigation, CAPA, or market action
QA personnel perform verification, oversight, and escalation support but do not
approve stability outcomes independently.
Family Pack Anchor
Section 6 — Auditable Artifacts (AA)
AA-QA-STABILITY — Stability Program Record
This artifact documents stability program authorization, execution evidence,
and QA oversight supporting shelf-life and product suitability.
Minimum evidentiary expectations include:
- Approved stability protocol reference
- Sample identity, lot, and storage condition
- Stability test data packages
- Trend review and assessment
- Escalations, investigations, or disposition decisions
Auditor focus: confirmation that stability programs are authorized, controlled,
reviewed, and support labeled shelf-life.
Section 7 — WIN (Control Requirements)
WIN-QA-STABILITY
Governs QA oversight and verification of stability programs.
- Verify approved stability protocols are in place.
- Confirm sample identity and storage conditions.
- Review stability data completeness.
- Escalate excursions or out-of-trend results.
Control outcome: stability data support continued product suitability and
shelf-life claims.
Authority Statement:
The AA and WIN above are authoritative and maintained under formal change control
within the QA Family Pack. This Execution Guide reproduces them verbatim for
execution support only.
BPO-Owned Execution Zone — WIN Execution Guide
Step 1 — Verify Stability Protocol Authorization
- Confirm an approved stability protocol exists for the product.
- Verify protocol version and applicability.
- Stability activities without authorization are escalated.
Step 2 — Verify Sample Identity & Storage Conditions
- Confirm stability sample identity and lot.
- Verify storage conditions align with protocol requirements.
- Condition excursions are escalated.
Step 3 — Review Stability Data Packages
- Confirm required test points and parameters are present.
- Verify data traceability and completeness.
- Missing or incomplete data are escalated.
Step 4 — Assess Trends & Exceptions
- Identify out-of-trend or atypical results.
- Verify escalation for investigations where required.
- Document observations for QCO review.
Step 5 — Prepare Evidence for QCO Review
- Compile stability records and trend summaries.
- Ensure traceability to product and labeling.
- Submit evidence for shelf-life or disposition decisions.
Authority Reminder
This WIN Execution Guide is non-authoritative and exists solely to support
execution. Stability acceptance, shelf-life decisions, and escalations are
rendered by the QCO under the QA Family Pack.
Consistency Assessment (Non-Authoritative)
Based on the provided text, the execution steps align with the intent and control
framework defined in the QA Family Pack. No conflicts identified.