Lifecycle Trending & Review Specification
This specification defines the Quality Unit–approved requirements governing lifecycle trending and periodic review of stability, complaints, deviations, and quality performance data to ensure continued product suitability.
Authoritative Quality Control specification defining lifecycle trending and review requirements and decision authority. This document does not define statistical tools, review meeting formats, or reporting templates.
1. Purpose
To establish Quality Unit–approved requirements for integrated lifecycle trending and review of product quality data to identify emerging risks, confirm continued suitability, and support proactive quality management throughout the product lifecycle.
2. Scope
This specification applies to all GMP products from initial release through end of shelf life, including ongoing commercial production and post-market oversight.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Production (PROD)
- Packaging (PKG)
- Regulatory Affairs
- Customer Service / Complaints Handling
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-004
Lifecycle trending and review requirements defined in this specification shall not be modified outside approved QMS change control.
4. Lifecycle Trending & Review Requirements
| Review Element | Requirement | Applicability |
|---|---|---|
| Data Integration | Lifecycle reviews shall consider relevant data from stability, complaints, deviations, investigations, and process performance. | All GMP products |
| Periodic Review | Lifecycle trending and review shall be conducted at defined intervals appropriate to product risk and lifecycle stage. | Commercial and post-approval products |
| Trend Identification | Data shall be evaluated to identify adverse trends, shifts, or recurring issues that may impact product quality. | All lifecycle data sets |
| Risk Evaluation | Identified trends shall be evaluated for potential quality, safety, and compliance impact. | All identified trends |
| Action Determination | Lifecycle reviews shall determine whether additional monitoring, investigation, CAPA, or program changes are required. | Adverse or emerging trends |
Lifecycle trending shall not be limited to single data streams and shall consider the totality of available quality information.
5. Decision Logic
- Stable lifecycle performance supports continued routine operation.
- Emerging or adverse lifecycle trends require evaluation and potential action.
- Lifecycle reviews may result in changes to stability programs, shelf life assignments, or control strategies.
- Final determinations regarding lifecycle trend significance and response reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Adverse trends impacting product quality or shelf life
- Recurring complaints or stability failures
- Conflicting interpretations of lifecycle data
- Potential regulatory or market impact identified
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Lifecycle trending and review reports
- Integrated quality data summaries
- Risk assessments and impact evaluations
- Quality Unit decisions and action determinations