Stability Program Governance Specification

This specification defines the Quality Unit–approved requirements governing the establishment, oversight, and control of stability programs used to support shelf life, expiry, and ongoing product suitability decisions.

Specification Type:
Authoritative Quality Control specification defining stability program governance and decision authority. This document does not define stability study execution, test methods, or storage procedures.

1. Purpose

To establish Quality Unit–approved governance requirements for stability programs, ensuring that stability data is suitable to support shelf life, expiry dating, and ongoing assessment of product quality throughout the product lifecycle.

2. Scope

This specification applies to all GMP products subject to stability evaluation, including commercial products, development lots used to support shelf life, and products subject to ongoing stability monitoring.

Applicable Business Domains include:

Quality Control (QC)
Quality Assurance (QA)
Laboratory Operations
Warehouse Operations (WH)
Regulatory Affairs

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-STAB-001

Stability program governance requirements defined in this specification shall not be modified outside approved QMS change control.

4. Stability Program Governance Requirements

Governance Element	Requirement	Applicability
Program Definition	Stability programs shall be formally defined, documented, and approved prior to use.	All stability programs
Study Design Suitability	Stability studies shall be appropriate to the product, packaging, storage conditions, and intended shelf life.	All stability evaluations
Test Attribute Selection	Stability programs shall include test attributes relevant to product quality, safety, and performance.	All stability studies
Ongoing Oversight	Stability data shall be periodically reviewed to confirm continued product suitability throughout shelf life.	Ongoing and post-approval stability programs
Change Impact Evaluation	Product, process, or packaging changes shall be evaluated for potential impact on stability programs and shelf life.	Changes impacting stability

Stability programs shall generate data sufficient to support initial shelf life assignment and ongoing verification of product quality.

5. Decision Logic

Stability data supporting acceptance criteria may be used to justify shelf life and expiry dating.
Adverse or unexpected stability trends require evaluation and potential escalation.
Stability data shall not be ignored or deferred when it indicates potential quality risk.
Final determinations regarding stability program adequacy and data interpretation reside with the Quality Unit.

6. Escalation Requirements

Quality Assurance must escalate to Quality Control or QCO when any of the following occur:

Stability results outside acceptance criteria
Adverse or worsening stability trends
Insufficient data to support labeled shelf life
Disagreement regarding interpretation of stability data

7. Records & Evidence

Records supporting compliance with this specification include, but are not limited to:

Approved stability protocols and programs
Stability test results and reports
Stability trend reviews and evaluations
Quality Unit decisions regarding shelf life and stability

This specification defines stability program governance and decision authority only. Stability study execution, testing schedules, storage conditions, and laboratory procedures are defined in separate controlled documents and shall not redefine the requirements herein.