3. Responsibilities

• QC Analyst: Perform stability sample testing as per defined intervals and STP.
• QA Officer: Monitor storage conditions and maintain stability chambers.
• Stability Coordinator: Maintain inventory, pull schedules, and data compilation.
• QC Reviewer: Verify results and compile interim and final stability reports.

4. Accountability

The Head – Quality is accountable for the scientific justification, regulatory compliance, and execution of the stability program for API batches.

5. Procedure

5.1 Study Design

1. Refer to ICH Q1A(R2) and ICH Q1E for designing stability protocols.
2. Include:
   • Study type (accelerated, long-term, intermediate)
   • Storage conditions (25°C/60% RH, 30°C/65% RH, 40°C/75% RH)
   • Testing intervals (e.g., 0, 3, 6, 9, 12, 18, 24 months)
   • Specifications to be monitored (appearance, assay, impurities, moisture content, etc.)

5.2 Sample Storage

1. Stability samples must be:
   • Representative of production batches
   • Packed in containers that simulate market packaging
   • Labeled with unique stability ID, batch number, storage condition, and interval schedule
2. Place samples in qualified stability chambers monitored continuously using calibrated temperature and humidity sensors.

5.3 Testing Procedure

1. At each interval, withdraw samples per schedule and perform testing as per STP.
2. Ensure all tests are conducted within ±5 days of the scheduled interval date.
3. Use validated analytical methods and retain all chromatograms and raw data for review.
4. Document observations such as color change, precipitation, or odor.

5.4 Data Compilation and Evaluation

1. Compare results against acceptance criteria and note any trends.
2. Prepare interim reports after each interval and a comprehensive report at the end of the study.
3. Include graphical trends for key parameters (e.g., assay, impurity).

5.5 Out-of-Trend or OOS Results

1. If any OOT or OOS result is observed:
   • Notify QA immediately
   • Initiate deviation/investigation
   • Conduct root cause analysis
   • Evaluate impact on shelf-life and future batches

5.6 Record Keeping and Archival

1. All stability data, test records, and reports must be retained for at least 5 years post expiry of the batch.
2. Ensure electronic and physical copies are secured and backed up.

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• STP: Standard Test Procedure
• OOS: Out of Specification
• OOT: Out of Trend
• ICH: International Council for Harmonisation
• RH: Relative Humidity

7. Documents

1. Stability Protocol
2. Stability Sample Inventory Log (Annexure-1)
3. Stability Pull and Testing Log (Annexure-2)
4. Stability Reports

8. References

• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• ICH Q1E – Evaluation of Stability Data
• 21 CFR Part 211 – US FDA cGMP
• WHO Technical Report Series 1010

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 Sample Inventory Log

Date	Stability ID	Batch No.	Condition	Container Qty	Initial Weight
13/04/2025	STB-API-001	API-20250413	25°C/60% RH	10	500 g

Annexure-2: Stability Pull and Testing Log

Date	Stability ID	Interval	Tests Performed	Analyst	Reviewed By
13/07/2025	STB-API-001	3 Months	Assay, Impurity	Sunita Reddy	Rajesh Kumar

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	Regulatory Requirement	QA Head
13/04/2025	2.0	Inclusion of pull log and OOT section	Audit Observation	QA Head