Procedure for Viscosity Testing in Topical Preparations
1) Purpose
The purpose of this SOP is to outline the procedure for testing viscosity in topical preparations to ensure consistency and adherence to specified viscosity ranges.
2) Scope
This SOP applies to all topical preparations requiring viscosity testing as part of quality control measures to assess product performance and consistency.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing viscosity testing.
Quality Assurance (QA) Department: Responsible for review and approval of viscosity testing procedures and results.
Manufacturing Department: Responsible for providing topical preparation samples and support during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Ensure topical preparation samples are thoroughly mixed to homogenize the formulation.
4.1.2 Use samples that are representative of the batch and free from air bubbles.
4.2 Calibration of Viscometer:
4.2.1 Calibrate the viscometer using standard viscosity calibration fluids (e.g., silicone oils) before testing.
4.2.2 Verify the accuracy of the viscometer readings against calibration standards.
4.3 Viscosity Measurement:
4.3.1 Place the prepared sample into the viscometer chamber.
4.3.2 Allow sufficient time for the sample to reach thermal equilibrium if temperature control is required.
4.3.3 Record viscosity readings at specified rotational speeds or shear rates as per method requirements.
4.4 Measurement Reproducibility:
4.4.1 Repeat viscosity
4.4.2 Ensure agreement in viscosity measurements within acceptable tolerance limits.
4.5 Cleaning and Maintenance:
4.5.1 Clean the viscometer and chamber thoroughly between measurements to prevent contamination.
4.5.2 Store the viscometer and accessories properly after use as per manufacturer instructions.
4.6 Data Recording:
4.6.1 Record viscosity measurement values, calibration details, and any deviations observed during testing.
4.6.2 Document all viscosity measurement results accurately in the appropriate records.
4.7 Reporting:
4.7.1 Prepare a Viscosity Testing Report summarizing test procedures, results, and conclusions.
4.7.2 Include any corrective actions or recommendations based on viscosity testing findings.
4.7.3 Submit the report to QA for review and approval and maintain records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Viscosity Testing Report
Calibration Records
Sample Testing Records
7) Reference, if any
USP (insert appropriate reference for topical preparations)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0