Tablets: SOP for Ensuring Regulatory Compliance in Stability Studies – V 2.0
Standard Operating Procedure for Ensuring Regulatory Compliance in Stability Studies
| Department |
Tablet |
| SOP No. |
SOP/TAB/228/2025 |
| Supersedes |
SOP/TAB/228/2022 |
| Page No. |
Page 1 of 5 |
| Issue Date |
01/04/2026 |
| Effective Date |
06/04/2026 |
| Review Date |
01/04/2027 |
1. Purpose
The purpose of this SOP is to establish a consistent approach for ensuring regulatory compliance during stability studies for tablet products. This SOP outlines the steps necessary to ensure that stability studies meet international regulatory requirements, including those set by the FDA, ICH, and other regulatory bodies.
2. Scope
This SOP applies to all tablet stability studies conducted within the organization, including accelerated, long-term, and real-time stability studies. It covers the procedures for designing, conducting, and reporting stability studies, as well as the documentation required to ensure regulatory compliance.
3. Responsibilities
- QA Manager: Ensures that stability studies are conducted in compliance with applicable regulations and that all documentation is properly maintained.
- Stability Study Coordinator: Responsible for planning and coordinating stability studies, including selecting the appropriate study conditions and sampling plans.
- Regulatory Affairs Team: Ensures that stability studies comply with applicable regulatory guidelines, such as ICH Q1A (R2), 21 CFR Part 211, and other relevant local regulations.
- Laboratory Staff: Conducts the stability testing according to the defined protocols and records data accurately.
4. Accountability
The QA Manager is accountable for ensuring that all stability studies comply with regulatory requirements. The Stability Study Coordinator is responsible for overseeing the implementation of the study protocols and ensuring that all testing is completed on schedule.
5. Procedure
5.1 Study Design
- Identify the tablet product that requires stability testing based on its shelf life, formulation, and intended market (Annexure-1).
- Define the stability study design, including the study conditions, sampling frequency, and testing parameters. Ensure that the study design aligns with ICH Q1A (R2) guidelines for stability testing (Annexure-2).
- Ensure that the appropriate test methods and analytical procedures are selected for the study, and ensure compliance with any regulatory requirements (Annexure-3).
- Obtain approval of the stability study design from the QA Manager and Regulatory Affairs team before initiating the study.
5.2 Stability Conditions
- Ensure that stability studies are conducted under appropriate environmental conditions, such as temperature, humidity, and light exposure, as specified in the regulatory guidelines (Annexure-4).
- Use calibrated equipment to monitor and control environmental conditions throughout the study period.
- Ensure that stability chambers are properly validated and that they meet the specifications for long-term, accelerated, and stress stability testing (Annexure-5).
5.3 Sampling and Testing
- Collect samples from the stability chambers according to the predefined sampling plan, ensuring that the samples represent different batches and testing time points (Annexure-6).
- Perform the necessary analytical tests on the samples, such as dissolution, assay, and microbial limits, in accordance with the regulatory guidelines (Annexure-7).
- Ensure that all testing is performed using validated methods and that test results are recorded in the appropriate documentation systems (Annexure-8).
5.4 Data Review and Compliance Check
- Review all test data to ensure that the results meet regulatory requirements, including the acceptance criteria for stability (Annexure-9).
- Ensure that all test results are documented properly, including any deviations or out-of-specification results. Investigate any discrepancies and take corrective actions if necessary (Annexure-10).
- Ensure that all stability study data is reviewed by the QA Manager and Regulatory Affairs team to ensure regulatory compliance before submission to regulatory bodies (Annexure-11).
5.5 Reporting and Documentation
- Prepare a stability study report that includes all relevant data, including test results, environmental conditions, and conclusions (Annexure-12).
- Ensure that the stability study report complies with all applicable regulatory guidelines and includes all required information, such as shelf life, storage conditions, and packaging recommendations (Annexure-13).
- Submit the stability study report to the Regulatory Affairs team for review and approval before submission to regulatory authorities (Annexure-14).
5.6 Regulatory Submission and Approval
- Submit the finalized stability study report to regulatory authorities, ensuring that it complies with all local and international guidelines (Annexure-15).
- Maintain copies of the submission, as well as any correspondence with regulatory authorities regarding the study (Annexure-16).
- Ensure that any updates or amendments required by regulatory authorities are incorporated into the final report.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- ICH: International Council for Harmonisation
- FDA: Food and Drug Administration
- CFR: Code of Federal Regulations
- GMP: Good Manufacturing Practice
7. Documents
- Stability Study Design Document (Annexure-1)
- Stability Study Conditions and Testing Protocol (Annexure-2)
- Test Methods and Analytical Procedures (Annexure-3)
- Stability Chamber Validation Records (Annexure-4)
- Sampling Plan and Schedule (Annexure-5)
- Test Results (Annexure-6)
- Test Method Validation Records (Annexure-7)
- Stability Study Data Log (Annexure-8)
- Review and Compliance Records (Annexure-9)
- Stability Study Report (Annexure-10)
- Regulatory Submission and Approval Documentation (Annexure-11)
- Stability Study Final Report (Annexure-12)
- Regulatory Submission Documentation (Annexure-13)
- Correspondence with Regulatory Authorities (Annexure-14)
8. References
- ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
9. SOP Version
Version: 2.0
10. Approval Section
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Approved By |
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11. Annexures
Annexure-1: Stability Study Design Document
| Product Name |
Study Type |
Test Methods |
Study Duration |
Sampling Frequency |
| Product A |
Long-term Stability |
Dissolution, Assay |
12 months |
Every 3 months |
Annexure-2: Stability Study Conditions and Testing Protocol
| Storage Condition |
Temperature |
Humidity |
Light Exposure |
| Accelerated |
40°C |
75% |
Light |
Annexure-3: Test Methods and Analytical Procedures
| Test Method |
Parameter Tested |
Standard Method |
| Dissolution |
Dissolution Rate |
USP <711> |
Annexure-4: Stability Chamber Validation Records
| Chamber |
Validation Date |
Temperature |
Humidity |
| Stability Chamber 1 |
01/02/2025 |
25°C |
60% |
Annexure-5: Sampling Plan and Schedule
| Sampling Time Point |
Batch No. |
Sampling Quantity |
| 0 months |
Batch 001 |
10 tablets |
Annexure-6: Test Results
| Test |
Result |
Acceptance Criteria |
| Dissolution |
95% release |
Not less than 80% |
Annexure-7: Test Method Validation Records
| Test Method |
Validation Type |
Validation Results |
| Dissolution |
USP Validation |
Passed |
Annexure-8: Stability Study Data Log
| Study Date |
Test Parameter |
Result |
| 01/02/2025 |
Dissolution |
95% |
Annexure-9: Review and Compliance Records
| Reviewer |
Review Date |
Comments |
| John Doe |
05/03/2025 |
No deviations |
Annexure-10: Stability Study Report
| Study Conclusion |
Recommended Action |
| Stable for 12 months |
No action required |
Annexure-11: Regulatory Submission and Approval Documentation
| Submission Date |
Regulatory Authority |
Approval Status |
| 10/03/2025 |
FDA |
Approved |
Annexure-12: Stability Study Final Report
| Final Conclusion |
Recommended Shelf Life |
| Stable for 24 months |
24 months |
Annexure-13: Regulatory Submission Documentation
| Submission Date |
Document |
Status |
| 10/03/2025 |
Final Report |
Submitted |
Annexure-14: Correspondence with Regulatory Authorities
| Correspondence Date |
Subject |
Status |
| 12/03/2025 |
Submission Approval |
Approved |
Revision History:
| Revision Date |
Revision No. |
Revision Details |
Reason for Revision |
Approved By |
| 01/01/2024 |
1.0 |
Initial SOP creation |
New process |
QA Head |
| 01/02/2025 |
2.0 |
Updated stability study design and procedures |
Process improvement |
QA Head |