Standard Operating Procedure for Emulsion Stability Testing

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting emulsion stability testing of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure the stability and efficacy of the product.

2) Scope

This SOP applies to all personnel involved in the emulsion stability testing of pharmaceutical formulations within the pharmaceutical manufacturing facility. It covers the procedures for sample preparation, testing, and data analysis.

3) Responsibilities

– Quality Control (QC) Department: Responsible for conducting emulsion stability tests and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for emulsion stability testing as per the testing protocol.

4) Procedure

4.1 Sample Preparation
4.1.1 Collect representative samples of the emulsion formulation as per the sampling plan.
4.1.2 Ensure samples are properly labeled with batch number and storage conditions.
4.2 Testing Conditions
4.2.1 Store samples under specified conditions such as room temperature, refrigerated conditions, and accelerated stability conditions.
4.2.2 Perform stability testing at predetermined intervals, such as 0, 1, 3, 6, 9, and 12 months.
4.3 Stability Testing
4.3.1 Evaluate the physical appearance of the emulsion, checking for signs of phase separation, creaming, or sedimentation.
4.3.2 Measure droplet size distribution using techniques such as dynamic light scattering (DLS) or laser diffraction.
4.3.3 Conduct centrifugation tests to assess the stability of the emulsion under stress conditions.
4.3.4 Perform pH measurement and viscosity testing to monitor any changes over time.
4.4 Data Analysis
4.4.1 Record all test results in the emulsion stability testing logbook or electronic database.
4.4.2 Compare the results against predefined specifications to determine the stability of the emulsion.
4.5 Documentation
4.5.1 Document all observations, measurements, and test results.
4.5.2 Ensure that all records are reviewed and approved by the QC department.
4.6 Reporting
4.6.1 Prepare a stability testing report summarizing the methodology, results, and any observations.
4.6.2 Submit the report to the QA department for review and approval.
4.7 Corrective Actions
4.7.1 If any stability parameter fails to meet specifications, initiate an investigation to identify the root cause.
4.7.2 Implement corrective actions as necessary and document all findings and actions taken.

5) Abbreviations, if any

– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
– DLS: Dynamic Light Scattering

6) Documents, if any

– Emulsion Stability Testing Logbook
– Stability Testing Reports
– Batch Records

7) Reference, if any

– ICH Q1A(R2): Stability Testing of New Drug Substances and Products
– USP <729> Globule Size Distribution in Lipid Injectable Emulsions

8) SOP Version

Version 1.0