Standard Operating Procedure for Stability Data Review for Regulatory Filing
| Department | Regulatory Affairs |
| SOP No. | RA/2026/708 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 13/04/2026 |
| Effective Date | 13/04/2026 |
| Review Date | 13/04/2028 |
Purpose
This SOP defines the standardized process for the systematic review of stability data intended for regulatory filing. It ensures compliance with regulatory requirements and internal quality standards by providing clear instructions for data verification, evaluation, documentation, and approval associated with stability studies supporting regulatory submissions. The objective is to maintain data integrity, support timely dossier preparation, and facilitate regulatory acceptance.
Scope
This procedure covers the review of stability data generated for all pharmaceutical dosage forms and products intended for registration and regulatory filing across all therapeutic areas. It includes data generated from in-house and contract laboratories and applies to all stability reports and associated documentation intended for submission to regulatory authorities. Exclusions include raw stability data generation and sample analysis, which are governed under separate SOPs.
Responsibilities
- Regulatory Affairs Team: Execute stability data review activities, ensuring completeness and regulatory compliance.
- Quality Assurance (QA): Supervise and verify the review process and approve final review outcomes.
- Data Management/Analytical Teams: Provide required raw and processed stability data and support clarifications.
- Document Control: Maintain and archive reviewed stability data and review reports.
Accountability
The Head of Regulatory Affairs is accountable for ensuring the SOP is implemented effectively, remains compliant with regulatory and internal quality requirements, is periodically reviewed for continuing suitability, and that any deviations or non-compliances are escalated and addressed promptly.
Procedure
1. Preparation and Receipt
a. Confirm receipt of complete stability data packages including raw data, analytical reports, summary tables, and previous review comments if applicable.
b. Verify that data corresponds to the batch and study protocol under review.
2. Prerequisites and Checks
a. Ensure that prerequisite SOPs on stability study conduct, analytical procedure validation, and data integrity are followed.
b. Confirm that all data are generated under validated systems and comply with GMP and GxP requirements.
c. Check that storage conditions, sampling time points, and testing methods align with the approved stability protocol.
3. Data Review and Evaluation
a. Conduct a thorough line-by-line review of the stability report comparing reported values against raw data sheets.
b. Validate calculations, graphical presentations, and trending analyses.
c. Assess the data against pre-defined acceptance criteria, regulatory guidelines, and internal specifications.
d. Identify any anomalies, missing data, or deviations and document observations in a structured comments log.
e. Engage with analytical or stability teams to clarify discrepancies or request additional information as necessary.
4. Approval and Documentation
a. Compile review findings and confirm resolution of all queries.
b. Prepare the Stability Data Review Report, indicating acceptance or need for further investigations.
c. Obtain documented approval/sign-off from authorized QA and Regulatory Affairs reviewers.
d. Ensure all final documents are version controlled and submitted to the document control team.
5. Record Retention and Closure
a. Archive all reviewed data, review reports, and correspondence as per company record retention policy.
b. Monitor for any post-filing regulatory queries and facilitate additional data review as required.
c. Schedule periodic review of this SOP to ensure ongoing adequacy and compliance.
6. Deviation Handling
a. Any deviations observed during review shall be recorded and investigated according to the deviation management SOP.
b. Implement corrective and preventive actions if necessary.
This procedure is designed to ensure that stability data supporting regulatory filings are accurate, complete, and compliant, thereby facilitating smooth regulatory approval and maintaining product quality assurance throughout its shelf life.
Abbreviations
- GMP – Good Manufacturing Practice
- GxP – Good Practice (General term for quality guidelines)
- QA – Quality Assurance
- RA – Regulatory Affairs
- SOP – Standard Operating Procedure
Documents
- Stability Data Review Report Template (Annexure-1)
- Stability Summary Table Format (Annexure-2)
- Stability Review Comments Log (Annexure-3)
References
- ICH Q1A(R2): Stability Testing of New Drug Substances and Products
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- EU GMP Annex 11 – Computerized Systems
- Company Quality Manual and Data Integrity Policy
- ICH Q10: Pharmaceutical Quality System
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Stability Data Review Report Template
Purpose: To document the results, observations, and final conclusion of the stability data review in a standardized format for regulatory filing.
| Report No. | SDRR/2026/001 |
| Product Name | Example Product A |
| Batch No. | BP202604 |
| Study Start Date | 01/01/2025 |
| Study Completion Date | 31/12/2025 |
| Reviewer | Regulatory Affairs Reviewer |
| Review Date | 10/04/2026 |
| Summary | Stability data reviewed for full 12-month period; all results within specification. No deviations noted. Data suitable for regulatory submission. |
| Comments | None |
| Approval Signature | Authorized QA Approval |
| Approval Date | 12/04/2026 |
Annexure-2: Stability Summary Table Format
Purpose: To provide a tabulated summary of critical stability parameters tested at various time points as evidence for data review and filing.
| Parameter | Initial | 3 Months | 6 Months | 9 Months | 12 Months |
|---|---|---|---|---|---|
| Appearance | Clear, Colorless | Clear, Colorless | Clear, Colorless | Clear, Colorless | Clear, Colorless |
| Assay (%) | 100.2 | 99.8 | 99.5 | 99.3 | 99.1 |
| pH | 6.8 | 6.7 | 6.7 | 6.6 | 6.6 |
| Impurities (%) | 0.05 | 0.07 | 0.08 | 0.09 | 0.10 |
Annexure-3: Stability Review Comments Log
Purpose: To record and track comments, queries, actions, and resolutions arising during the review of stability data.
| Date | Comment/Observation | Raised By | Action Taken | Status | Closed By |
|---|---|---|---|---|---|
| 05/04/2026 | Assay value at 9 months borderline; request raw data verification. | Regulatory Reviewer | Raw data confirmed; no deviation found. | Closed | QA Verifier |
| 08/04/2026 | Missing expiry dating in report footer. | Regulatory Reviewer | Added expiry dating as per protocol. | Closed | QA Verifier |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 13/04/2026 | 1.0 | Initial issue | New SOP creation |