Responsibilities

• Quality Control (QC): Responsible for physical collection of stability samples and maintaining logs.
• Production: Ensure samples are available and appropriately labeled.
• Quality Assurance (QA): Oversees the process and ensures proper documentation and compliance.

4. Accountability

The Head – Quality Assurance is accountable for ensuring the reliability and integrity of sampling practices for stability testing.

5. Procedure

5.1 Sampling Time Points

1. Conduct sampling at predefined intervals based on the stability protocol: 0, 1, 3, 6, 9, 12, 18, and 24 months.
2. Follow accelerated testing intervals (e.g., 0, 3, 6 months) as per ICH Q1A(R2).

5.2 Preparation for Sampling

1. Review the approved stability protocol and determine the test schedule.
2. QC personnel should verify the chamber condition and label integrity before initiating sampling.
3. Ensure sampling tools, containers, and labels are clean and approved.

5.3 Sampling Procedure

1. Use clean, dry, inert containers (glass or HDPE jars) for collecting samples.
2. Withdraw representative samples from the stability batch, maintaining container closure integrity.
3. Sample quantity should be sufficient for all tests, including retain samples and repeats.
4. Label each sample clearly with:
   • Batch number
   • Date of manufacture
   • Sampling date
   • Storage condition
   • Stability time point

5.4 Documentation

1. Record details of sampling in the Stability Sample Logbook (Annexure-1).
2. Attach sampling labels (Annexure-2) to each sample container.
3. Update the Stability Protocol Log (Annexure-3) for traceability.

5.5 Handling of Samples

1. Transfer samples promptly to QC for analysis or store under specified conditions if analysis is delayed.
2. Do not reintroduce any unused sample back into the chamber.

5.6 Deviations and Issues

1. In case of sampling deviation (missed time point, incorrect labeling), report immediately to QA.
2. Document deviation using the Stability Deviation Form (Annexure-4).

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• HDPE: High-Density Polyethylene
• ICH: International Council for Harmonisation

7. Documents

1. Stability Sample Logbook – Annexure-1
2. Sample Label Format – Annexure-2
3. Stability Protocol Log – Annexure-3
4. Stability Deviation Form – Annexure-4

8. References

• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• WHO Technical Report Series 953
• Schedule M – Good Manufacturing Practices

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 Sample Logbook

Date	Batch No.	Time Point	Storage Condition	Collected By	Remarks

Annexure-2: Sample Label Format

Label Field	Entry
Product Name
Batch Number
Stability Time Point
Sampling Date
Storage Condition
QC Analyst Initials

Annexure-3: Stability Protocol Log

Batch No.	Protocol No.	Time Point	Status	Remarks
			Completed/Pending

Annexure-4: Stability Deviation Form

Date	Batch No.	Deviation Observed	Action Taken	Reviewed By

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 deviation handling and new annexures	Periodic Review	QA Head