Ointments: SOP for Long-Term Stability Testing – V 2.0

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SOP for Long-Term Stability Testing – V 2.0

Procedure for Long-Term Stability Testing

Department	Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D)
SOP No.	SOP/Ointment/102
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting long-term stability testing of ointments to assess their physical, chemical, and microbiological stability over an extended period under recommended storage conditions.

2. Scope

This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments responsible for executing, monitoring, and documenting long-term stability studies.

3. Responsibilities

QC Analyst: Conducts stability testing at predefined intervals.
QC Supervisor: Ensures compliance with the stability study protocol.
QA Officer: Reviews stability study data and ensures adherence to guidelines.
R&D Scientist: Analyzes data trends and recommends formulation adjustments if needed.
QA Manager: Approves stability study protocols and ensures regulatory compliance.

4. Accountability

The QA and QC Managers are accountable for ensuring that long-term stability testing is conducted as per ICH Q1A(R2) guidelines.

5. Procedure

5.1 Preparation for Stability Testing

Ensure the stability study protocol is approved before initiating the study.
Select representative ointment batches for testing.
Label samples with batch number, manufacturing date, and storage conditions.
Store samples under recommended long-term conditions as per

ICH guidelines (e.g., 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH, depending on regulatory requirements).

5.2 Stability Testing Parameters

Physical Properties: Assess changes in appearance, color, odor, and texture.
Chemical Stability: Analyze the active ingredient content using validated analytical methods.
Microbiological Testing: Perform microbial limit tests for contamination.
pH Measurement: Evaluate changes in pH levels over time.
Viscosity Analysis: Determine changes in consistency and spreadability.

5.3 Sampling Intervals

Collect samples for testing at predefined intervals: 0, 3, 6, 9, 12, 18, 24, and 36 months.
Perform all tests as per the approved stability study protocol.
Record observations and test results in the Stability Testing Log.

5.4 Handling Out-of-Specification (OOS) Results

Identify deviations from acceptance criteria.
Initiate an Out-of-Specification (OOS) investigation if required.
Implement corrective and preventive actions (CAPA) as necessary.

5.5 Documentation and Data Analysis

Record test results in the Stability Study Report.
Ensure data integrity and traceability.
QA must review and approve stability data before finalizing the report.

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
ICH – International Council for Harmonisation
RH – Relative Humidity
OOS – Out-of-Specification

7. Documents

Stability Testing Log (Annexure-1)
Long-Term Stability Study Report (Annexure-2)

8. References

ICH Q1A(R2) Stability Testing of New Drug Substances and Products
WHO GMP Guidelines for Pharmaceutical Stability Studies

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 Testing Log

Date	Batch Number	Storage Condition	Testing Interval	Parameter Tested	Result	Reviewed By
01/02/2025	OINT-201	25°C/60% RH	6 Months	Viscosity	Compliant	QA Officer
01/08/2025	OINT-201	25°C/60% RH	12 Months	pH	Stable	QA Officer

Annexure-2: Long-Term Stability Study Report

Batch Number	Study Start Date	Study End Date	Test Parameters	Results	Final Conclusion
OINT-201	01/02/2025	01/02/2028	pH, Viscosity, Microbial Limits	Compliant	Meets Stability Criteria
OINT-202	01/03/2025	01/03/2028	Appearance, Assay, Microbial Limits	Compliant	Meets Stability Criteria

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head