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 for homogeneity testing, such as HPLC, UV spectroscopy, or another validated method.
4.3.2 Calibrate the analytical equipment according to the manufacturer’s instructions and ensure it is functioning correctly.
4.4 Measurement
4.4.1 Analyze each sample using the selected analytical method.
4.4.2 Record the concentration of the API in each sample and calculate the mean and standard deviation.
4.5 Data Analysis
4.5.1 Compare the concentrations of the API in different samples to assess uniformity.
4.5.2 Ensure that the variation in API concentration across the samples is within the acceptable limits specified in the product specification.
4.6 Documentation
4.6.1 Document all test results, including raw data, calculations, and observations, in the homogeneity testing logbook or electronic database.
4.6.2 Ensure that all records are reviewed and approved by the QC department.
4.7 Reporting
4.7.1 Prepare a homogeneity testing report summarizing the methodology, results, and any deviations observed.
4.7.2 Submit the report to the QA department for review and approval.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
– HPLC: High-Performance Liquid Chromatography
6) Documents, if any
– Homogeneity Testing Logbook
– Analytical Method Validation Records
– Homogeneity Testing Reports
7) Reference, if any
– ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
– USP <905> Uniformity of Dosage Units
8) SOP Version
Version 1.0
