Procedure for Conducting Accelerated Stability Testing During Development
| Department | Research and Development (R&D)/Quality Assurance (QA)/Quality Control (QC)/Stability Studies |
|---|---|
| SOP No. | SOP/Ointment/182 |
| 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 approach for conducting accelerated stability testing during the development phase of pharmaceutical ointments. This ensures that the formulation maintains its intended quality, safety, and efficacy under stress conditions, in compliance with regulatory guidelines.
2. Scope
This SOP applies to all personnel involved in stability studies, formulation development, quality control, and regulatory compliance in the Research and Development (R&D), Quality Assurance (QA), and Quality Control (QC) departments.
3. Responsibilities
- Stability Study Coordinator: Plans and executes stability testing protocols.
- QA Officer: Ensures adherence to ICH stability guidelines.
- QC Analyst: Conducts physical, chemical, and microbiological testing.
- R&D Scientist: Analyzes stability results for formulation optimization.
- Regulatory Affairs Specialist: Ensures documentation meets compliance standards.
4. Accountability
The R&D Manager is accountable for ensuring that all stability testing activities comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Selection of Formulations for Stability Testing
- Identify prototype formulations that require accelerated stability testing.
- Ensure formulations are:
- Representative of the final product composition.
- Properly packaged in suitable
containers.
Free from visible defects.
5.2 Preparation of Stability Testing Protocol
- Prepare a protocol specifying:
- Testing conditions (temperature, humidity).
- Sampling intervals (0, 1, 3, 6 months, etc.).
- Parameters to be tested (appearance, pH, viscosity, microbial load).
- Ensure protocol approval by the QA department before execution.
5.3 Storage Conditions for Accelerated Stability Testing
- Follow ICH Q1A (R2) guidelines:
- **Accelerated Condition:** 40°C ± 2°C / 75% RH ± 5% RH.
- **Intermediate Condition:** 30°C ± 2°C / 65% RH ± 5% RH.
- Use validated **stability chambers** with continuous monitoring.
- Record environmental conditions in the **Stability Study Log (Annexure-1).**
5.4 Stability Testing Parameters
- Conduct **physical tests**:
- Appearance (color, texture, phase separation).
- pH measurement.
- Viscosity analysis.
- Perform **chemical tests**:
- Assay of active pharmaceutical ingredients (APIs).
- Degradation product analysis.
- Conduct **microbiological tests**:
- Total viable count.
- Pathogen screening (E. coli, S. aureus, P. aeruginosa).
- Document results in the **Stability Test Report (Annexure-2).**
5.5 Evaluation of Stability Results
- Compare test results with initial baseline values.
- Identify any trends in degradation.
- Determine if the formulation meets shelf-life expectations.
- Summarize findings in the **Stability Summary Report.**
5.6 Corrective Actions for Stability Failures
- If a sample fails stability testing:
- Investigate potential causes (packaging, excipient interactions).
- Modify formulation or packaging as needed.
- Conduct repeat stability testing after corrective measures.
- Document all changes in the **Corrective and Preventive Action (CAPA) Report.**
5.7 Approval and Reporting
- QA must review and approve stability data before submission to regulatory authorities.
- Final stability reports must be stored for a minimum of **five years**.
6. Abbreviations
- API – Active Pharmaceutical Ingredient
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- FDA – Food and Drug Administration
7. Documents
- Stability Study Log (Annexure-1)
- Stability Test Report (Annexure-2)
8. References
- ICH Q1A (R2) – Stability Testing of New Drug Substances and Products
- WHO Guidelines on Stability Studies
- FDA Guidance on Stability Testing for Pharmaceuticals
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 Log
| Date | Batch No. | Storage Condition | Time Point | QC Review |
|---|---|---|---|---|
| 02/02/2025 | STB-1001 | 40°C / 75% RH | 3 Months | Approved |
Annexure-2: Stability Test Report
| Date | Batch No. | Test Parameter | Initial Value | Final Value | QA Approval |
|---|---|---|---|---|---|
| 02/02/2025 | STB-1001 | pH | 6.8 | 6.7 | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Stability Testing Protocols | Improved Compliance | QA Head |