Shelf Life Assignment Specification

This specification defines the Quality Unit–approved requirements governing assignment, justification, extension, and maintenance of product shelf life and expiry dating for GMP products.

Specification Type:
Authoritative Quality Control specification defining shelf life assignment requirements and decision authority. This document does not define statistical modeling, stability study execution, or labeling procedures.

1. Purpose

To establish Quality Unit–approved requirements ensuring that assigned shelf life and expiry dating are scientifically justified, supported by stability data, and maintained throughout the product lifecycle.

2. Scope

This specification applies to all GMP products requiring shelf life or expiry dating, including initial assignments, extensions, reductions, or confirmation of labeled shelf life.

Applicable Business Domains include:

Quality Control (QC)
Quality Assurance (QA)
Laboratory Operations
Regulatory Affairs
Supply Chain & Labeling

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-003

Shelf life assignment requirements defined in this specification shall not be modified outside approved QMS change control.

4. Shelf Life Assignment Requirements

Assignment Element	Requirement	Applicability
Data Support	Shelf life assignments shall be supported by appropriate stability data generated under defined storage conditions.	All shelf life assignments
Initial Assignment	Initial shelf life shall be conservatively assigned based on available stability data and product knowledge.	New or modified products
Extension or Reduction	Changes to assigned shelf life shall be justified by additional data and approved prior to implementation.	Shelf life revisions
Ongoing Verification	Assigned shelf life shall be periodically confirmed through ongoing stability monitoring.	Commercial products
Label Alignment	Shelf life and expiry dating shall be consistent with approved labeling and regulatory commitments.	Labeled products

Shelf life assignments shall reflect the earliest point at which product quality may no longer meet acceptance criteria under labeled storage conditions.

5. Decision Logic

Shelf life supported by adequate stability data may be assigned or maintained.
Insufficient or adverse stability data require conservative assignment or reduction of shelf life.
Shelf life shall not be extended without prior Quality Unit approval.
Final determinations regarding shelf life assignment reside with the Quality Unit.

6. Escalation Requirements

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

Stability data indicates potential shelf life failure
Conflicting interpretations of stability results
Proposed shelf life extension without sufficient data
Labeling or regulatory concerns related to expiry dating

7. Records & Evidence

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

Shelf life assignment justifications
Stability data and trend analyses
Quality Unit approvals for shelf life decisions
Regulatory and labeling alignment documentation

This specification defines shelf life assignment requirements and decision authority only. Statistical analysis methods, stability study execution, and labeling operations are defined in separate controlled documents and shall not redefine the requirements herein.