Procedure for Homogeneity Testing in Creams and Ointments
1) Purpose
The purpose of this SOP is to outline the procedure for testing the homogeneity of creams and ointments to ensure uniform distribution of active pharmaceutical ingredients (APIs) and excipients.
2) Scope
This SOP applies to all creams and ointments manufactured within the facility that require homogeneity testing as part of quality control.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting homogeneity testing and ensuring compliance with this SOP.
Production Department: Responsible for providing cream and ointment samples and supporting QC during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Obtain representative samples of creams or ointments from different batches.
4.1.2 Mix samples thoroughly using a suitable method (e.g., manual stirring, mechanical mixer) to ensure uniformity.
4.1.3 Use appropriate sample sizes to reflect the intended use and packaging configuration.
4.2 Homogeneity Testing:
4.2.1 Select a suitable sampling procedure to ensure representative portions of the sample are tested.
4.2.2 Perform homogeneity testing using validated methods (e.g., content uniformity testing, visual inspection).
4.2.3 Analyze sample portions for uniform distribution of APIs and excipients according to established specifications.
4.3 Interpretation of Results:
4.3.1 Evaluate test results to determine if the sample meets acceptance criteria for homogeneity.
4.3.2 Compare test results against predefined limits or pharmacopeial standards.
4.3.3 Document any deviations or out-of-specification results and initiate investigation as per defined procedures.
4.4 Acceptance Criteria:
4.4.1 Creams and ointments are considered homogeneous if the variation in API and excipient content is within acceptable limits.
4.4.2 Ensure all testing parameters and acceptance criteria comply with method validation and regulatory requirements.
4.5 Documentation:
4.5.1 Record all homogeneity testing procedures, results, and observations in the Homogeneity Testing Record.
4.5.2 Maintain detailed records of sample details, testing conditions, equipment calibration, and any corrective actions taken.
4.5.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
API: Active Pharmaceutical Ingredient
6) Documents, if any
Homogeneity Testing Record
Equipment Calibration Certificates
Sampling Plan Document
7) Reference, if any
USP General Chapter <905> – Uniformity of Dosage Units
Pharmacopeial standards for Homogeneity Testing in Creams and Ointments
8) SOP Version
Version 1.0
