new and ongoing gel formulations at the Gel Manufacturing Department.

3. Responsibilities

• Quality Control Analyst: Prepares, updates, and maintains primary stability test records.
• Stability Coordinator: Ensures timely collection of data and completion of stability records.
• Quality Assurance (QA): Reviews, verifies, and approves stability data records and logbooks.

4. Accountability

Head – Quality Assurance is accountable for ensuring compliance with stability record maintenance in line with cGMP and regulatory requirements.

5. Procedure

5.1 Stability Protocol Documentation

1. Ensure that a signed and approved stability protocol is available before initiation of any stability study.
2. Include study design, time points, storage conditions, product details, batch numbers, sampling schedule, and acceptance criteria in the protocol.
3. Maintain protocol in the Stability Master File (Annexure-1).

5.2 Test Data and Result Documentation

1. Record analytical test results, observations, and instrument printouts at each stability time point in a standardized format (Annexure-2).
2. Ensure each entry is signed, dated, and reviewed by the respective department head or designee.

5.3 Storage of Records

1. All stability records should be archived in a dedicated, secure, and access-controlled document storage area.
2. Stability records shall be stored in chronological order with clear labeling of product name, batch number, and time points.

5.4 Access and Retrieval

1. Only authorized QA or regulatory staff may access archived stability data.
2. Use the Stability Record Retrieval Log (Annexure-3) for all record movement entries.

5.5 Electronic Records

1. Maintain a digital backup of stability data in a validated Document Management System (DMS) with restricted access and version control.
2. Regularly back up electronic data as per IT SOPs and ensure audit trails are in place.

5.6 Record Retention Period

1. Stability records must be retained for at least one year beyond product expiry or as per regulatory requirement, whichever is later.

5.7 Destruction of Records

1. Obsolete or expired records should be discarded only after written approval from QA and with destruction logs maintained (Annexure-4).

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• DMS: Document Management System
• cGMP: Current Good Manufacturing Practices

7. Documents

1. Stability Study Protocol – Annexure-1
2. Stability Test Result Template – Annexure-2
3. Record Retrieval Log – Annexure-3
4. Destruction Authorization Log – Annexure-4

8. References

• ICH Q1A (R2) Stability Testing of New Drug Substances and Products
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO TRS No. 1010 Annex 10

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Stability Study Protocol Format

Product Name
Batch No.
Storage Condition
Test Parameters
Acceptance Criteria
Time Points	0, 1M, 3M, 6M, 9M, 12M, 18M, 24M
Approved By

Annexure-2: Stability Test Result Template

Time Point	Assay (%)	pH	Viscosity	Appearance	Comments
0M
1M
3M

Annexure-3: Stability Record Retrieval Log

Date	Record Name	Retrieved By	Purpose	Returned On	Verified By (QA)

Annexure-4: Destruction Authorization Log

Date	Record ID	Details	Approved By	Destroyed By	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Version	New SOP	QA Head
02/06/2025	2.0	Added digital archive handling and annexure formats	Regulatory Requirement	QA Head