Procedure for Documentation of Stability Study Results
| Department | Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/107 |
| 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 the process for documenting stability study results for ointments. This ensures that stability data is recorded systematically, analyzed accurately, and maintained for regulatory compliance.
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments responsible for recording, reviewing, and maintaining stability study results.
3. Responsibilities
- QC Analyst: Records stability test results at defined intervals.
- QC Supervisor: Reviews data accuracy and ensures compliance with study protocols.
- QA Officer: Verifies the completeness and correctness of stability documentation.
- R&D Scientist: Analyzes data trends and provides recommendations if necessary.
- QA Manager: Approves final documentation and ensures compliance with regulatory guidelines.
4. Accountability
The QA and QC Managers are accountable for ensuring stability study documentation aligns with ICH Q1A(R2) guidelines.
5. Procedure
5.1 Data Recording Requirements
- Ensure that all stability study results are documented in a pre-approved format.
- Each data entry must include:
- Batch number
- Storage condition
- Testing interval
- Parameter tested
- Result obtained
- Name and signature of the analyst
5.2 Stability Data Analysis
- Analyze stability data for trends and significant variations.
- Compare results against predefined acceptance criteria.
- Document any deviations and initiate Out-of-Specification (OOS) procedures if necessary.
5.3 Review and Approval Process
- QC Supervisor reviews raw data for accuracy and completeness.
- QA Officer verifies results and ensures data integrity.
- Final approval of the stability study report by the QA Manager.
5.4 Handling Deviations and Out-of-Specification (OOS) Results
- Document deviations and OOS findings in the Stability Deviation Log.
- Investigate and identify the root cause of any stability failures.
- Implement corrective and preventive actions (CAPA) if necessary.
5.5 Storage and Retention of Stability Study Data
- Store stability records in a secure, controlled-access location.
- Ensure compliance with regulatory record retention policies (e.g., minimum 5 years after product expiry).
- Maintain electronic backups for long-term storage.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- OOS – Out-of-Specification
- CAPA – Corrective and Preventive Action
7. Documents
- Stability Study Result 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
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 Result Log
| Date | Batch Number | Storage Condition | Testing Interval | Parameter Tested | Result | Reviewed By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-701 | 25°C/60% RH | 6 Months | Viscosity | Compliant | QA Officer |
| 01/08/2025 | OINT-701 | 25°C/60% RH | 12 Months | pH | Stable | QA Officer |
Annexure-2: Final Stability Study Report
| Batch Number | Study Start Date | Study End Date | Test Parameters | Results | Final Conclusion |
|---|---|---|---|---|---|
| OINT-701 | 01/02/2025 | 01/02/2028 | pH, Viscosity, Microbial Limits | Compliant | Meets Stability Criteria |
| OINT-702 | 01/03/2025 | 01/03/2028 | Appearance, Assay, Microbial Limits | Compliant | Meets Stability Criteria |
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 |