Standard Operating Procedure for Homogeneity Testing in Gels
1) Purpose
The purpose of this SOP is to define procedures for conducting homogeneity testing on gel products to ensure uniform distribution of ingredients and consistency in quality.
2) Scope
This SOP applies to all personnel involved in homogeneity testing of gel products within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC) Analyst: Perform homogeneity testing according to this SOP.
Production Operators: Provide samples and assist in testing as required.
Quality Assurance (QA) Team: Review and approve homogeneity testing procedures and results.
4) Procedure
4.1 Sampling
4.1.1 Select representative samples from each batch of gel product for testing.
4.1.2 Ensure samples are taken aseptically and in sufficient quantity for testing.
4.2 Preparation of Test Samples
4.2.1 Prepare samples for testing by following specified extraction or dilution procedures.
4.2.2 Ensure samples are adequately mixed and homogeneous before testing.
4.3 Testing Method
4.3.1 Use validated analytical methods (e.g., spectroscopy, chromatography) for homogeneity testing.
4.3.2 Perform tests according to defined parameters and acceptance criteria.
4.4 Evaluation of Results
4.4.1 Evaluate test results against established acceptance criteria for homogeneity.
4.4.2 Record observations and any deviations
4.5 Reporting and Documentation
4.5.1 Document homogeneity testing activities including procedures, results, and conclusions.
4.5.2 Maintain complete and traceable records of homogeneity testing for batch records.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Homogeneity Testing Records
– SOP for Sample Preparation and Handling
– Batch Production Records
7) Reference, if any
– USP General Chapter <905> Uniformity of Dosage Units
– ICH Q2(R1): Validation of Analytical Procedures
– Company-specific homogeneity testing guidelines
8) SOP Version
Version 1.0