Standard Operating Procedure for Viscosity Testing

1) Purpose

This SOP outlines the procedures for determining the viscosity of pharmaceutical liquids or semi-solids.

2) Scope

This SOP applies to viscosity testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing viscosity testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the viscosity testing protocol and ensure all necessary materials and equipment are available (e.g., viscometer, calibration standards).
2. Verify the calibration and functionality of the viscometer.

4.2 Sample Collection and Preparation

1. Collect representative samples of liquids or semi-solids according to sampling procedures.
2. Ensure proper labeling and identification of samples.
3. If necessary, precondition the samples to the specified temperature or allow them to equilibrate.

4.3 Testing Procedure

1. Calibrate the viscometer using calibration standards covering the expected viscosity range of the samples.
2. Fill the viscometer with the sample and allow it to stabilize.
3. Record the viscosity reading once stable conditions are achieved.
4. Perform viscosity determination in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the viscosity values of the tested samples meet the specified acceptance criteria based on compendial standards or product specifications.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a viscosity testing report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Viscosity Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <911> Viscosity, European Pharmacopoeia (Ph. Eur.) 2.2.10 Viscosity

8) SOP Version

Version 1.0