throughout the study period.

4. Accountability

The QA Manager is responsible for overseeing the recordkeeping process and ensuring compliance with this SOP. The QC Manager is responsible for ensuring that stability study records are completed accurately and promptly.

5. Procedure

5.1 Planning and Initiating Stability Studies

Follow these steps when initiating stability studies:

1. Define Stability Study Protocol
   1. Collaborate with the R&D team to develop a stability study protocol that includes the product details, study conditions (e.g., temperature, humidity), and time intervals for testing.
   2. Ensure that the study protocol includes all required testing parameters (e.g., dissolution, assay, appearance) and compliance with regulatory guidelines.
2. Prepare Stability Study Records
   1. Prepare a stability study logbook or electronic record that will track all relevant data for the duration of the study.
   2. Record study start and end dates, testing conditions, and relevant identifiers (e.g., batch numbers, product codes).

5.2 Conducting Stability Tests

During the stability study, follow these steps for testing and documentation:

1. Perform Stability Testing
   1. At each time interval specified in the study protocol, perform the required stability tests (e.g., dissolution, assay, pH, appearance).
   2. Ensure that testing is conducted according to the established methods and that all test parameters are documented.
2. Document Test Results
   1. Record the results of all tests in the stability study logbook or electronic record.
   2. Ensure that results are clearly written or entered, including test conditions, test methods, and any deviations or anomalies observed during testing.

5.3 Review of Stability Data

Follow these steps for reviewing stability study data:

1. Data Review by QC Team
   1. The QC team must review all stability test results for accuracy and compliance with the study protocol.
   2. Ensure that results are compared against the specifications set in the study protocol to determine if the capsules meet stability requirements.
2. Approval by QA Team
   1. The QA team will review the stability study data, including test results and any observed deviations, to ensure compliance with GMP and regulatory standards.
   2. After review, QA will approve the stability study data for inclusion in the final report.

5.4 Final Stability Report and Archiving

Once the stability study is complete, follow these steps for reporting and archiving:

1. Prepare Stability Study Report
   1. Prepare a final stability study report that includes all test results, observations, conclusions, and recommendations.
   2. The report should summarize the data obtained during the study and provide any necessary actions based on the results (e.g., product shelf life determination).
2. Archive Stability Study Records
   1. All stability study records, including raw data, reports, and test results, should be archived in a secure location for future reference and regulatory inspections.
   2. Ensure that records are organized and easily retrievable based on batch number, product type, and study date.
3. Retain Records for Required Period
   1. Stability study records should be retained for the duration required by regulatory guidelines (typically 5 years or as required by local regulations).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis
• BPR: Batch Packing Record

7. Documents

1. Annexure 1: Stability Study Logbook Template
2. Annexure 2: Stability Testing Protocol
3. Annexure 3: Final Stability Study Report Template

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q1A – Stability Testing of New Drug Substances and Products

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 Logbook Template

Batch Number	Product Name	Test Date	Test Parameters	Test Results	Remarks
Batch 001	Capsule A	01/03/2025	Dissolution	Pass	Within specifications

Annexure 2: Stability Testing Protocol

Test Parameter	Method	Frequency	Temperature	Humidity
Dissolution	USP Type 2 Apparatus	Every 3 months	25°C	60%

Annexure 3: Final Stability Study Report Template

Batch Number	Product Name	Stability Period	Conclusion	Shelf Life
Batch 001	Capsule A	24 months	Stable under prescribed conditions	36 months

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for stability study recordkeeping	QA Head
01/02/2025	2.0	Updated stability testing methods and protocols	Revised to incorporate updated testing standards	QA Head