Standard Operating Procedure for Homogeneity Testing in Lotions

1) Purpose

The purpose of this SOP is to outline procedures for conducting homogeneity testing on lotion samples to ensure uniform distribution of ingredients throughout the batch.

2) Scope

This SOP applies to all personnel involved in the quality control and assurance of lotions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Quality Control (QC) Analysts:

• Perform homogeneity testing on lotion samples according to approved procedures and protocols.
• Document and report testing results accurately and promptly.

Quality Assurance (QA) Personnel:

• Review and approve homogeneity testing protocols and results.
• Ensure compliance with SOPs and regulatory requirements.

Production Personnel:

• Support QC analysts by providing access to production batches and assisting with sample collection.
• Implement corrective actions based on homogeneity testing outcomes as necessary.

4) Procedure

4.1 Sampling:

• Select representative samples from different locations within the lotion batch according to approved sampling plan.
• Ensure samples are properly labeled with batch information and sampling details.

4.2 Sample Preparation:

• Prepare lotion samples for testing by following specified sample preparation procedures.
• Ensure samples are homogenized and ready for analysis to accurately represent the batch.

4.3 Testing Method:

• Perform homogeneity testing using appropriate analytical techniques, such as content uniformity testing or visual inspection methods.
• Follow validated testing methods and procedures to assess uniformity of lotion samples.

4.4 Data Analysis:

• Analyze testing results to determine the degree of homogeneity across the lotion batch.
• Compare results against acceptance criteria and established specifications.

4.5 Reporting:

• Document homogeneity testing results accurately, including methods used, observations, and conclusions.
• Report findings to QA for review and approval before further batch processing or release.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QC: Quality Control

QA: Quality Assurance

6) Documents, if any

• Homogeneity Testing Protocols
• Testing Results and Reports
• Batch Records

7) Reference, if any

• ICH Q2 (R1): Validation of Analytical Procedures
• USP <905>: Uniformity of Dosage Units

8) SOP Version

Version 1.0