to all sterile injectable products manufactured in-house and intended for stability testing during product development and commercial production stages.

3. Responsibilities

• QA Department: Responsible for protocol approval, monitoring storage conditions, and ensuring data integrity.
• QC Department: Responsible for analysis of stability samples as per schedule.
• Production Department: Responsible for providing properly labeled samples to QA for placement.

4. Accountability

The Head of Quality Assurance is accountable for ensuring compliance with stability protocols, regulatory submissions, and maintaining the integrity of the stability program.

5. Procedure

5.1 Preparation of Stability Protocol

1. Prepare a stability protocol for each product as per ICH Q1A(R2) guidelines including:
   • Test parameters
   • Storage conditions
   • Testing schedule
   • Acceptance criteria
2. Get protocol reviewed by QC, approved by QA.

5.2 Sampling and Labeling

1. Collect samples from production batches intended for real-time or accelerated studies.
2. Ensure samples are representative, in final packaging configuration.
3. Label samples with:
   • Batch No.
   • Date of manufacture
   • Storage condition
   • Stability study type

5.3 Storage Conditions

1. Store samples under controlled environmental conditions as defined in protocol:
   • 25°C ± 2°C / 60% RH ± 5% RH
   • 30°C ± 2°C / 65% RH ± 5% RH
   • 40°C ± 2°C / 75% RH ± 5% RH
   • 2–8°C (refrigerated)
2. Monitor temperature and humidity using calibrated data loggers.

5.4 Testing Schedule

1. Follow the predefined time points:
   • Accelerated: 0, 3, 6 months
   • Long-term: 0, 3, 6, 9, 12, 18, 24 months (as applicable)
2. Withdraw samples for testing and log the withdrawal in Stability Withdrawal Log (Annexure-1).

5.5 Stability Testing

1. Perform testing as per the analytical method validated for the product.
2. Parameters may include:
   • Assay
   • Degradation products
   • pH
   • Appearance
   • Sterility
   • Particulate matter
3. Record results in Stability Data Sheet (Annexure-2).

5.6 Data Review and Trending

1. QA to review and approve stability results.
2. Prepare trend reports using statistical tools and compare with acceptance criteria.
3. Investigate any out-of-trend (OOT) or out-of-specification (OOS) results as per deviation SOP.

5.7 Reporting

1. Prepare interim and final stability reports and store in central stability file.
2. Include data in regulatory submissions, renewal applications, and Annual Product Quality Review (APQR).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• ICH: International Council for Harmonisation
• OOT: Out of Trend
• OOS: Out of Specification

7. Documents

1. Stability Sample Withdrawal Log – Annexure-1
2. Stability Data Sheet – Annexure-2
3. Stability Trend Report Format – Annexure-3

8. References

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• WHO Technical Report Series 1010 – Stability Testing Guidelines
• ICH Q1E: Evaluation for Stability Data

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Executive	QA Executive	Head QA
Department	Quality Control	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Stability Sample Withdrawal Log

Date	Batch No.	Storage Condition	Time Point	Withdrawn By
01/06/2025	IVS-2025-07	25°C/60% RH	3M	Ravi Patel

Annexure-2: Stability Data Sheet

Parameter	Initial	3M	6M	9M
Assay (%)	99.5	98.7	98.2	97.9
pH	5.6	5.6	5.5	5.5
Appearance	Clear	Clear	Clear	Clear

Annexure-3: Stability Trend Report Format

Product	Batch	Time Points	Parameter	Trend Observed
IVS	IVS-2025-07	0M–9M	Assay	Within limits

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP	New inclusion	QA Head
18/06/2025	2.0	Updated testing intervals, annexure formats	Annual Review	QA Head