Procedure for Managing Stability Study Data
| Department | Quality Control (QC)/Quality Assurance (QA)/Regulatory Affairs |
|---|---|
| SOP No. | SOP/Ointment/110 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a systematic process for managing stability study data. This ensures accuracy, integrity, and regulatory compliance for all stability study records maintained throughout a product’s lifecycle.
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Regulatory Affairs departments responsible for collecting, recording, analyzing, and maintaining stability study data.
3. Responsibilities
- QC Analyst: Records stability data, maintains logs, and reports deviations.
- QC Supervisor: Reviews raw data and ensures compliance with study protocols.
- QA Officer: Verifies the accuracy, completeness, and consistency of stability data.
- Regulatory Affairs Officer: Ensures data integrity for regulatory submissions.
- QA Manager: Approves final stability reports and ensures adherence to ICH Q1A(R2) guidelines.
4. Accountability
The QA and Regulatory Affairs Managers are accountable for ensuring proper management of stability study data and compliance with applicable regulatory requirements.
5. Procedure
5.1 Data Collection and Documentation
- Ensure that stability study data is recorded in approved formats and follows Good Documentation Practices (GDP).
- Each data entry must include:
- Batch number
- Manufacturing date
- Storage conditions
- Testing intervals (e.g., 0, 3, 6, 9, 12, 18, 24, 36 months)
- Testing parameters (pH, viscosity, assay, microbial limits, etc.)
- Results obtained
- Name and signature of the analyst
- Use validated software or physical logbooks for data entry to prevent errors.
5.2 Data Verification and Review
- QC Supervisor must verify raw data for completeness, consistency, and accuracy.
- QA Officer cross-checks the data against predefined acceptance criteria.
- Any discrepancies or missing data must be documented and investigated.
- Data must be signed off by both QC and QA personnel before being finalized.
5.3 Data Integrity and Compliance
- Ensure adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
- Electronic data must be protected by audit trails to prevent unauthorized modifications.
- All changes or corrections must be documented with proper justification.
- Ensure compliance with FDA 21 CFR Part 11 (for electronic records) and WHO GMP requirements.
5.4 Data Storage and Retention
- All stability study data must be securely stored in designated locations.
- Hard copy records must be archived in locked storage cabinets accessible only to authorized personnel.
- Electronic data must be backed up regularly and stored in a validated system with restricted access.
- Records must be retained for at least five years after the product expiry date, as per regulatory requirements.
5.5 Handling Out-of-Trend (OOT) and Out-of-Specification (OOS) Results
- If stability data deviates from expected trends (OOT), an initial investigation must be conducted.
- If a parameter fails to meet acceptance criteria (OOS), initiate an OOS investigation.
- Identify the root cause of deviations and implement Corrective and Preventive Actions (CAPA).
- All findings and actions taken must be documented in the Stability Deviation Log.
5.6 Stability Data Reporting
- Compile stability study data into summary reports at predefined intervals.
- Include statistical analysis to identify trends and potential stability issues.
- QA Manager must review and approve the final stability study report.
- Reports must be available for regulatory inspections and product registrations.
5.7 Regulatory Compliance and Audit Readiness
- Ensure stability data is audit-ready for regulatory agencies (FDA, EMA, WHO, etc.).
- Regularly review data management practices to maintain compliance.
- Provide necessary stability documentation for regulatory filings.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- OOT – Out-of-Trend
- OOS – Out-of-Specification
- CAPA – Corrective and Preventive Action
- GDP – Good Documentation Practices
- ALCOA+ – Attributable, Legible, Contemporaneous, Original, Accurate
7. Documents
- Stability Study Data Log (Annexure-1)
- Final Stability Study Report (Annexure-2)
8. References
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products
- WHO GMP Guidelines for Pharmaceutical Stability Studies
- FDA 21 CFR Part 11 – Electronic Records and Signatures
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Stability Study Data Log
| Batch Number | Testing Interval | Parameter | Result | Reviewed By |
|---|---|---|---|---|
| OINT-1001 | 6 Months | pH | Stable | QA Officer |
| OINT-1002 | 12 Months | Viscosity | Within Limits | QA Officer |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |