Standard Operating Procedure for Homogeneity Testing in Creams
1) Purpose
The purpose of this SOP is to outline the procedures for conducting homogeneity testing in creams to ensure uniform distribution of active ingredients and excipients throughout the product.
2) Scope
This SOP applies to all personnel involved in the production and quality control of creams, including production operators, quality control (QC) technicians, and quality assurance (QA) personnel. It covers procedures for sample collection, testing, and documentation.
3) Responsibilities
It is the responsibility of production operators to prepare samples, QC technicians to perform homogeneity testing, and QA personnel to review and approve test results.
4) Procedure
4.1 Preparation for Homogeneity Testing
4.1.1 Review the batch record and identify the points in the production process where samples need to be collected for homogeneity testing.
4.1.2 Ensure all testing equipment and containers are clean, dry, and suitable for the type of sample being collected.
4.1.3 Label sample containers with necessary information, including sample ID, batch number, date, and time of collection.
4.1.4 Wear appropriate personal protective equipment (PPE) such as gloves, lab coat, and hairnet to avoid contamination.
4.2 Collection of Samples
4.2.1 Follow the specific sampling instructions provided in the sampling plan, including the volume or weight of the sample to
4.2.2 Use clean sampling tools (e.g., spatulas, scoops) to collect samples from multiple locations within the batch to ensure representativeness (e.g., top, middle, bottom of the mixing vessel).
4.2.3 Immediately transfer the collected samples into the labeled containers and seal them tightly.
4.2.4 Record details of the sampling process in the sampling log, including the sample ID, batch number, date, time, and any observations.
4.3 Homogeneity Testing
4.3.1 Prepare the samples for testing according to the standard operating procedures specific to the analytical method being used (e.g., HPLC, UV-Vis spectroscopy).
4.3.2 Perform the homogeneity test on each sample, ensuring that the method used is validated and appropriate for detecting variations in the concentration of active ingredients or excipients.
4.3.3 Analyze the results to determine the uniformity of the samples. The results should be within the specified acceptance criteria for homogeneity.
4.3.4 Document the test results, including any deviations from the acceptance criteria, in the homogeneity testing log.
4.4 Handling and Storage of Samples
4.4.1 Handle samples with care to avoid contamination, degradation, or loss during the testing process.
4.4.2 Store samples under conditions specified in the sampling plan (e.g., refrigerated, room temperature) until testing is performed.
4.4.3 Label storage areas with appropriate information to ensure proper identification and retrieval of samples.
4.4.4 Monitor storage conditions regularly to ensure compliance with specified requirements.
4.5 Documentation and Review
4.5.1 Ensure all details of the sample collection and homogeneity testing process are accurately recorded in the homogeneity testing log and any associated forms.
4.5.2 Maintain records of sample collection, handling, testing, and results according to company policy and regulatory requirements.
4.5.3 Review and approve the homogeneity testing results by QA personnel.
4.5.4 Ensure that documentation is complete, accurate, and readily accessible for review by QA personnel or regulatory inspectors.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
PPE: Personal Protective Equipment
HPLC: High-Performance Liquid Chromatography
SOP: Standard Operating Procedure
6) Documents, if any
Batch Records
Sampling Plan
Homogeneity Testing Log
Sample Collection Forms
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
USP (United States Pharmacopeia) General Chapter on Uniformity of Dosage Units
8) SOP Version
Version 1.0