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 to avoid contamination during preparation.
4.4 Testing Method
4.4.1 Perform microscopic examination of cream samples to confirm the presence and identity of foreign particulate matter.
4.4.2 Follow established procedures for microscopic examination, including sample preparation and examination parameters.
4.5 Acceptance Criteria
4.5.1 Establish acceptance criteria for foreign particulate matter based on regulatory requirements and product specifications.
4.5.2 Classify particulate matter based on size, type, and potential impact on product safety and quality.
4.6 Documentation and Reporting
4.6.1 Document all foreign particulate matter testing activities, including sampling, visual inspection, microscopic examination, results, and observations.
4.6.2 Prepare testing reports summarizing test conditions, results, conclusions, and recommendations.
4.6.3 Obtain approval from Quality Control Management for foreign particulate matter testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Foreign Particulate Matter Testing Protocols
Foreign Particulate Matter Testing Reports
Non-Conforming Material Reports
7) Reference, if any
USP
Company-specific testing procedures for foreign particulate matter
8) SOP Version
Version 1.0