Standard Operating Procedure for Homogeneity Testing

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting homogeneity testing of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure uniform distribution of the active pharmaceutical ingredient (API) throughout the product.

2) Scope

This SOP applies to all personnel involved in the homogeneity testing of pharmaceutical formulations within the pharmaceutical manufacturing facility. It covers the procedures from sample collection to data analysis and reporting.

3) Responsibilities

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

4) Procedure

4.1 Sample Collection
4.1.1 Collect representative samples from different locations within the batch to ensure a comprehensive assessment of homogeneity.
4.1.2 Label each sample with a unique identifier indicating the sample location and batch number.
4.2 Sample Preparation
4.2.1 Prepare the samples according to the specified method, ensuring that they are adequately mixed and ready for analysis.
4.2.2 If required, dissolve the samples in an appropriate solvent to create a uniform solution.
4.3 Testing Method
4.3.1 Select the appropriate analytical method