Standard Operating Procedure for Viscosity Testing

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting viscosity testing of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure consistency and appropriate flow characteristics of the product.

2) Scope

This SOP applies to all personnel involved in the viscosity testing of pharmaceutical formulations within the pharmaceutical manufacturing facility. It covers the procedures for sample preparation, measurement, and data analysis.

3) Responsibilities

– Quality Control (QC) Department: Responsible for performing viscosity tests and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for viscosity testing as per the testing protocol.

4) Procedure

4.1 Equipment and Materials
4.1.1 Ensure that the viscometer or rheometer is calibrated and maintained.
4.1.2 Prepare all necessary materials, including samples, solvents, and any required accessories.
4.2 Sample Preparation
4.2.1 Obtain representative samples of the formulation as per the sampling plan.
4.2.2 Ensure that samples are homogenous and free of air bubbles before testing.
4.3 Measurement
4.3.1 Set up the viscometer or rheometer according to the manufacturer’s instructions.
4.3.2 Load the prepared sample into the viscometer or rheometer.
4.3.3 Perform the viscosity measurement at the