Standard Operating Procedure for Lotion Stability Testing

1) Purpose

The purpose of this SOP is to outline the procedure for conducting stability testing of lotions to ensure the product maintains its quality, safety, and efficacy throughout its shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of lotions in the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Stability Testing Analysts:

• Perform stability testing according to this SOP and document results accurately.
• Ensure stability chambers are maintained and monitored.

Quality Control Personnel:

• Review and verify stability test results for accuracy and compliance with specifications.

Quality Assurance Personnel:

• Ensure that the stability testing program complies with regulatory requirements.

4) Procedure

4.1 Pre-Testing Preparation:

• Ensure all stability chambers are calibrated and set to the required conditions (e.g., temperature, humidity).
• Verify the availability of stability testing samples and necessary documentation.

4.2 Stability Testing Conditions:

1. Long-Term Testing:
   • Store samples at the recommended storage conditions (e.g., 25°C ± 2°C and 60% RH ± 5% RH).
   • Test at specific intervals (e.g., 0, 3, 6, 9, 12, 18, 24 months).
2. Accelerated Testing:
   • Store samples at elevated conditions (e.g., 40°C ± 2°C and 75% RH ± 5% RH).
   • Test at specific intervals (e.g., 0, 1, 2, 3, 6 months).
3. Intermediate Testing:
   • Store samples at intermediate conditions (e.g., 30°C ± 2°C and 65% RH ± 5% RH).
   • Test at specific intervals as required (e.g., 0, 6, 12 months).

4.3 Stability Testing Parameters:

1. Physical Tests:
   • Appearance: Inspect for changes in color, consistency, and separation.
   • Viscosity: Measure using a viscometer.
   • pH: Determine using a calibrated pH meter.
2. Chemical Tests:
   • Assay of Active Ingredient: Perform using HPLC or other suitable analytical methods.
   • Preservative Content: Analyze concentration using appropriate methods.
3. Microbiological Tests:
   • Total Aerobic Microbial Count: Perform microbial limit tests.
   • Pathogen Testing: Check for specified pathogens.

4.4 Documentation:

• Record all test results in the stability logbook and in the stability study report.
• Document any deviations and their investigations.

4.5 Review and Evaluation:

• Review stability data periodically to identify trends or issues.
• Generate a stability summary report at the end of the study.

5) Abbreviations, if any

HPLC: High-Performance Liquid Chromatography

RH: Relative Humidity

6) Documents, if any

• Stability Protocol
• Stability Logbook
• Stability Study Report

7) Reference, if any

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products

8) SOP Version

Version 1.0