Standard Operating Procedure for Accelerated Stability Testing of Tablets
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/100/2025 |
| Supersedes | SOP/TAB/100/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for performing accelerated stability testing on tablet formulations, ensuring that the tablets maintain their quality, efficacy, and safety under accelerated storage conditions.
2. Scope
This SOP applies to the accelerated stability testing of tablet products, ensuring that the tablets are stored under controlled conditions to simulate the effects of long-term storage in a shorter time frame.
3. Responsibilities
- Quality Control (QC): Responsible for conducting the accelerated stability testing, including sample preparation, testing, and recording results accurately.
- Quality Assurance (QA): Ensures that the accelerated stability testing procedure is followed and reviews the results for compliance with regulatory standards.
- Laboratory Personnel: Responsible for the preparation of samples, calibration of instruments, and execution of stability tests under the specified conditions.
4. Accountability
The QC Manager is accountable for ensuring that the accelerated stability testing is performed accurately and consistently. The QA Manager is responsible for reviewing the stability test results and approving the batch for release based on the data obtained.
5. Procedure
5.1 Sample Collection
- Collect a representative sample of tablets from the batch, as specified in the batch record or pharmacopeial guidelines (usually a minimum of 6 tablets or as specified).
- Ensure that the tablets are free from defects such as cracks, chips, or discoloration that could affect the stability testing results.
- Label the sample appropriately for identification during testing.
5.2 Preparation of Testing Apparatus
- Ensure that all laboratory equipment, such as stability chambers, temperature/humidity controllers, and test instruments, are calibrated and functioning properly.
- Set up the stability chamber to the required temperature and humidity conditions as per the accelerated stability test specifications (e.g., 40°C and 75% relative humidity).
- Ensure that the chamber is operating correctly, with continuous monitoring of temperature and humidity levels during the test period.
5.3 Performing Accelerated Stability Test
- Place the tablet samples in the stability chamber for the prescribed period (e.g., 6 months, typically accelerated to 3 months), ensuring that the sample containers are properly sealed and labeled.
- Monitor the storage conditions throughout the test period, making sure the temperature and humidity levels remain within the specified range.
- Remove the tablets from the chamber at the specified time points (e.g., 0, 1, 2, and 3 months) for testing.
- Perform the required quality control tests at each time point, which may include:
- Appearance testing
- Hardness testing
- Disintegration testing
- Dissolution testing
- Content uniformity or assay testing
5.4 Data Recording and Calculation
- Record all results from the stability tests, including appearance, hardness, dissolution, and any observed changes in the tablet characteristics (Annexure-1).
- Compare the results at each time point to the initial results to evaluate any changes or degradation in the tablet’s quality and stability.
- Calculate the percentage change in tablet characteristics, such as dissolution rate or assay, and document whether the tablets meet the stability acceptance criteria.
5.5 Acceptance Criteria
- The tablets must meet the specified quality criteria at each time point, including:
- Appearance: No significant color changes or discoloration
- Hardness: Should remain within the established range
- Disintegration: Tablets must disintegrate as per the specifications
- Dissolution: Dissolution profiles should remain within the established limits
- Assay: No significant loss in active pharmaceutical ingredient (API) content
- If any of the criteria are not met, investigate and document the findings in the deviation report (Annexure-2), and determine whether corrective action is required.
5.6 Documentation and Record-Keeping
- Document all stability testing results, including test methods, time points, and any deviations, in the batch record (Annexure-1).
- Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
- Maintain raw data, test results, and supporting documentation for future reference and regulatory compliance.
5.7 Post-Test Cleanup
- Clean all equipment used for stability testing, including the stability chamber, test instruments, and sample containers, according to the cleaning SOP to prevent cross-contamination between tests.
- Ensure that all testing equipment is properly maintained and calibrated for future use.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- RH: Relative Humidity
- HPLC: High-Performance Liquid Chromatography
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <1116> – Stability Testing of Drug Substances and Drug Products
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – 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: Batch Record
| Batch Number | Tablet Sample | Test Method | Initial Hardness (kg) | Hardness After 3 Months (kg) | Result |
|---|---|---|---|---|---|
| Batch 001 | Tablet Sample | Dissolution | 6.5 | 6.4 | Pass |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Tablet hardness decreased below specification | Adjusted formulation and re-tested | Jane Doe |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Testing Methodology | Refined stability testing protocols | QA Head |