Procedure for Real-Time Stability Monitoring
| Department | Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/105 |
| 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 real-time stability monitoring of ointments to assess their physical, chemical, and microbiological stability under actual storage conditions over the product’s shelf life.
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments responsible for conducting, monitoring, and documenting real-time stability studies.
3. Responsibilities
- QC Analyst: Conducts stability testing at predefined intervals.
- QC Supervisor: Ensures adherence to real-time stability study protocol.
- QA Officer: Reviews and approves stability test results.
- R&D Scientist: Analyzes data trends and recommends formulation improvements if required.
- QA Manager: Approves stability study protocols and ensures regulatory adherence.
4. Accountability
The QA and QC Managers are accountable for ensuring compliance with ICH Q1A(R2) guidelines for real-time stability testing.
5. Procedure
5.1 Preparation for Stability Monitoring
- Ensure that the real-time stability study protocol is approved before initiation.
- Select representative ointment batches for testing.
- Label stability samples with batch number, manufacturing date, and storage conditions.
- Store samples under the recommended storage conditions for the product (e.g., 25°C
± 2°C / 60% RH ± 5% RH or 30°C ± 2°C / 65% RH ± 5% RH).
5.2 Stability Monitoring Conditions
- Ensure samples are stored under conditions that mimic actual market conditions.
- Monitor temperature and humidity regularly using validated data loggers.
- Ensure no direct exposure to light or extreme environmental conditions.
5.3 Stability Testing Parameters
- Physical Properties: Assess appearance, color, odor, and phase separation.
- Chemical Stability: Analyze the active ingredient content and degradation products.
- Microbiological Testing: Conduct microbial limit tests to check for contamination.
- pH Measurement: Record any changes in pH over time.
- Viscosity Analysis: Evaluate consistency and spreadability.
5.4 Sampling Intervals
- Collect stability samples at predefined intervals: 0, 3, 6, 9, 12, 18, 24, and 36 months.
- Perform all tests as per the stability study protocol.
- Record observations and test results in the Stability Monitoring Log.
5.5 Handling Out-of-Specification (OOS) Results
- Identify any deviations from the acceptance criteria.
- Initiate an Out-of-Specification (OOS) investigation if required.
- Implement corrective and preventive actions (CAPA) as necessary.
5.6 Documentation and Data Analysis
- Record all test results in the Stability Study Report.
- Ensure data integrity and traceability.
- QA must review and approve stability data before finalizing the report.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- RH – Relative Humidity
- OOS – Out-of-Specification
7. Documents
- Stability Monitoring Log (Annexure-1)
- Real-Time 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 Monitoring Log
| Date | Batch Number | Storage Condition | Testing Interval | Parameter Tested | Result | Reviewed By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-501 | 25°C/60% RH | 6 Months | Viscosity | Compliant | QA Officer |
| 01/08/2025 | OINT-501 | 25°C/60% RH | 12 Months | pH | Stable | QA Officer |
Annexure-2: Real-Time Stability Study Report
| Batch Number | Study Start Date | Study End Date | Test Parameters | Results | Final Conclusion |
|---|---|---|---|---|---|
| OINT-501 | 01/02/2025 | 01/02/2028 | pH, Viscosity, Microbial Limits | Compliant | Meets Stability Criteria |
| OINT-502 | 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 |