Standard Operating Procedure for Foreign Particulate Matter Testing in Creams

1) Purpose

The purpose of this SOP is to define procedures for conducting foreign particulate matter testing on creams. This ensures that creams are free from visible foreign particles that could affect product quality and safety.

2) Scope

This SOP applies to the Quality Control Department and personnel responsible for conducting foreign particulate matter testing of creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.

3) Responsibilities

The Quality Control Manager is responsible for overseeing foreign particulate matter testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.

4) Procedure

4.1 Sampling

4.1.1 Select representative samples of creams from the batch for testing.

4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.

4.1.3 Label each sample with batch information and identification numbers.

4.2 Visual Inspection

4.2.1 Inspect each cream sample visually against a white or light-colored background under appropriate lighting conditions.

4.2.2 Use magnification devices if necessary to enhance visibility of particulate matter.

4.2.3 Record observations of any visible foreign particulate matter present in the samples.

4.3 Sample Preparation

4.3.1 Prepare cream samples as needed for further microscopic examination or other testing methods.

4.3.2 Handle samples carefully