Standard Operating Procedure for Consistency Testing in Gels

1) Purpose

The purpose of this SOP is to establish procedures for testing the consistency of gel formulations to ensure uniform texture and performance.

2) Scope

This SOP applies to all personnel involved in consistency testing of gel products within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Analyst: Perform consistency testing according to this SOP.
Formulation Scientists: Provide input on method selection and consistency requirements.
Quality Assurance (QA) Team: Review and approve consistency testing procedures and results.

4) Procedure

4.1 Sample Preparation
4.1.1 Prepare samples following specified guidelines to ensure representative analysis.
4.1.2 Ensure samples are properly mixed and free from air bubbles before testing.

4.2 Consistency Testing Methods
4.2.1 Use validated methods such as rheometry, penetrometry, or texture analysis to measure consistency.
4.2.2 Perform measurements under controlled conditions to ensure accuracy and reproducibility.

4.3 Data Collection and Analysis
4.3.1 Record measurements and observations from consistency tests.
4.3.2 Analyze data to determine consistency parameters such as viscosity, firmness, and spreadability.

4.4 Reporting and Documentation
4.4.1 Document consistency testing procedures, results, and analysis.
4.4.2 Maintain comprehensive records of consistency testing for batch records and regulatory compliance.

5) Abbreviations, if any

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

6) Documents, if any

– Consistency Testing Records
– Method Validation Reports
– SOP for Sample Preparation and Handling

7) Reference, if any

– USP General Chapter <912> Rheometry
– ICH Q2(R1): Validation of Analytical Procedures
– Company-specific consistency testing guidelines

8) SOP Version

Version 1.0