Procedure for Stability Testing in Varied Humidity Conditions
| Department | Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/103 |
| 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 procedure for conducting stability testing of ointments under varied humidity conditions to assess their physical, chemical, and microbiological stability when exposed to different environmental humidity levels.
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments responsible for executing, monitoring, and documenting humidity-controlled stability studies.
3. Responsibilities
- QC Analyst: Conducts stability testing under different humidity conditions.
- QC Supervisor: Ensures compliance with stability study protocols.
- QA Officer: Reviews stability test data for regulatory compliance.
- R&D Scientist: Interprets data trends and suggests 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 stability testing under different humidity conditions.
5. Procedure
5.1 Preparation for Stability Testing
- Ensure the 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 specified humidity conditions in stability chambers.
5.2 Storage Conditions for Humidity Testing
- 25°C ± 2°C / 40% RH ± 5% RH (Low Humidity Conditions)
- 25°C ± 2°C / 60% RH ± 5% RH (Standard Conditions)
- 30°C ± 2°C / 65% RH ± 5% RH (Intermediate Conditions)
- 40°C ± 2°C / 75% RH ± 5% RH (High Humidity Conditions)
5.3 Stability Testing Parameters
- Physical Properties: Observe changes in texture, phase separation, or liquefaction.
- Chemical Stability: Assess active ingredient content and degradation products.
- Microbiological Testing: Perform microbial limit tests to detect contamination.
- pH Measurement: Determine the impact of humidity on pH values.
- Viscosity Analysis: Evaluate changes in consistency and spreadability.
5.4 Sampling Intervals
- Collect stability samples at predefined intervals: 0, 3, 6, 9, 12, 18, and 24 months.
- Perform tests as per the stability study protocol.
- Document all test results in the Stability Testing 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 needed.
5.6 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)
- Humidity-Based 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-301 | 25°C/40% RH | 6 Months | Viscosity | Compliant | QA Officer |
| 01/08/2025 | OINT-301 | 40°C/75% RH | 12 Months | pH | Stable | QA Officer |
Annexure-2: Humidity-Based Stability Study Report
| Batch Number | Study Start Date | Study End Date | Test Parameters | Results | Final Conclusion |
|---|---|---|---|---|---|
| OINT-301 | 01/02/2025 | 01/02/2027 | pH, Viscosity, Microbial Limits | Compliant | Meets Stability Criteria |
| OINT-302 | 01/03/2025 | 01/03/2027 | 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 |