Procedure for Preparing Stability Study Reports
| Department | Quality Assurance (QA)/Quality Control (QC)/Research & Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/156 |
| 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 establish a systematic approach for preparing Stability Study Reports in pharmaceutical manufacturing. Stability studies evaluate the effect of environmental factors such as temperature, humidity, and light on drug products to determine their shelf life and storage conditions.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Research & Development (R&D) departments responsible for conducting stability studies, analyzing data, and preparing Stability Study Reports for regulatory compliance.
3. Responsibilities
- QC Analyst: Conducts stability tests and records analytical data.
- QA Officer: Reviews stability study reports for compliance.
- R&D Scientist: Designs and monitors stability studies.
- QA Manager: Approves final Stability Study Reports.
4. Accountability
The QA and R&D Managers are accountable for ensuring that Stability Study Reports comply with GMP, ICH, WHO, and FDA guidelines.
5. Procedure
5.1 Types of Stability Studies
Stability studies are classified into the following categories:
- Accelerated Stability Studies: Conducted at elevated temperature and humidity conditions to predict long-term stability.
- Long-Term Stability Studies: Conducted under normal storage conditions to determine real-time stability.
- Intermediate Stability Studies: Performed at conditions between long-term and accelerated studies.
- Photostability Studies: Evaluates the effect of light exposure on drug products.
5.2 Stability Study Protocol Development
- A Stability Study Protocol must be prepared before initiating stability testing.
- The protocol must include:
- Purpose and scope of the study.
- Batch details (Batch No., manufacturing and expiry date).
- Storage conditions and test intervals.
- Test parameters (e.g., assay, pH, viscosity, microbial limits).
- Acceptance criteria and test methods.
- The Stability Study Protocol must be reviewed and approved by the QA Manager.
5.3 Sample Preparation and Storage
- Stability samples must be collected from representative batches.
- Samples must be labeled with:
- Product name and batch number.
- Storage condition and test interval.
- Date of sample collection.
- Samples must be stored in **stability chambers** under defined conditions:
- Storage conditions:
- Accelerated: **40°C ± 2°C / 75% RH ± 5% RH**
- Long-Term: **25°C ± 2°C / 60% RH ± 5% RH**
- Intermediate: **30°C ± 2°C / 65% RH ± 5% RH**
- Photostability: **Light exposure per ICH guidelines**
5.4 Stability Testing and Data Recording
- QC must conduct tests at predefined intervals (e.g., 1 month, 3 months, 6 months, 12 months, 24 months).
- Tests include:
- Physical tests (appearance, odor, color).
- Chemical tests (assay, pH, degradation products).
- Microbiological tests (total viable count, endotoxin levels).
- All test results must be recorded in the **Stability Testing Log.**
5.5 Preparation of Stability Study Reports
- The Stability Study Report must include:
- Summary of stability testing results.
- Trend analysis of critical parameters.
- Degradation profile and extrapolated shelf life.
- Recommendations on storage conditions and expiry period.
- The report must be reviewed by the **QA Manager** before submission.
5.6 Review and Approval of Stability Study Reports
- QA must review stability data monthly.
- Regulatory compliance must be ensured before final approval.
- Reports must be archived for **a minimum of 5 years.**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- R&D – Research & Development
- RH – Relative Humidity
- ICH – International Council for Harmonisation
7. Documents
- Stability Study Protocol Template (Annexure-1)
- Stability Study Report Template (Annexure-2)
8. References
- ICH Q1A – Stability Testing of New Drug Substances
- WHO Guidelines on Stability Studies
- US FDA Guidance on Stability Testing
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 Protocol Template
| Product Name | Batch No. | Storage Condition | Test Interval | QA Approval |
|---|---|---|---|---|
| Ointment A | 12345 | 40°C/75% RH | 0, 1, 3, 6, 12 months | Approved |
Annexure-2: Stability Study Report Template
| Date | Test Parameter | Initial Value | 6-Month Value | 12-Month Value | QA Review |
|---|---|---|---|---|---|
| 02/02/2025 | Assay | 99.8% | 99.5% | 98.9% | Reviewed |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Procedure | Improved Documentation | QA Head |