Procedure for Accelerated Stability Testing of Ointments
| Department | Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/101 |
| 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 outline the procedure for conducting accelerated stability testing of ointments to evaluate the product’s physical, chemical, and microbiological stability under stressed environmental conditions.
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments involved in performing, monitoring, and documenting accelerated stability studies for ointments.
3. Responsibilities
- QC Analyst: Conducts stability testing as per the protocol.
- QC Supervisor: Ensures adherence to test conditions and data integrity.
- QA Officer: Reviews and approves stability testing reports.
- R&D Scientist: Interprets data and suggests formulation improvements if needed.
- QA Manager: Approves stability study protocols and ensures regulatory compliance.
4. Accountability
The QA and QC Managers are accountable for ensuring compliance with stability testing guidelines as per ICH Q1A(R2).
5. Procedure
5.1 Preparation for Stability Testing
- Ensure that the stability study protocol is approved before initiating testing.
- Select representative ointment batches for testing.
- Label stability samples with batch number, manufacturing date, and storage conditions.
- Store samples under specified accelerated conditions as per
ICH guidelines (e.g., 40°C ± 2°C/75% RH ± 5% RH).
5.2 Stability Testing Parameters
- Physical Properties: Observe changes in color, odor, texture, phase separation.
- Chemical Stability: Assess the active ingredient assay using validated analytical methods.
- Microbiological Testing: Perform microbial limit tests to check for contamination.
- pH Measurement: Record any variations in pH levels over time.
- Viscosity Analysis: Evaluate consistency and spreadability.
5.3 Sampling Intervals
- Collect stability samples at predefined intervals: 0, 1, 2, 3, and 6 months.
- Perform tests as per the stability study protocol.
- Record all observations in the Stability Testing Log.
5.4 Handling Out-of-Specification (OOS) Results
- Identify any deviations from the acceptance criteria.
- Initiate an OOS investigation if required.
- Implement corrective and preventive actions (CAPA) if necessary.
5.5 Documentation and Data Analysis
- Record all test results in the Stability Study Report.
- Ensure data integrity and traceability.
- QA must 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 Testing Log (Annexure-1)
- Accelerated 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 Testing Log
| Date | Batch Number | Storage Condition | Testing Interval | Parameter Tested | Result | Reviewed By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | 40°C/75% RH | 1 Month | Viscosity | Compliant | QA Officer |
| 01/03/2025 | OINT-101 | 40°C/75% RH | 3 Months | pH | Stable | QA Officer |
Annexure-2: Accelerated Stability Study Report
| Batch Number | Study Start Date | Study End Date | Test Parameters | Results | Final Conclusion |
|---|---|---|---|---|---|
| OINT-101 | 01/02/2025 | 01/08/2025 | pH, Viscosity, Microbial Limits | Compliant | Meets Stability Criteria |
| OINT-102 | 01/03/2025 | 01/09/2025 | 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 |