Standard Operating Procedure for Particulate Matter Testing
1) Purpose
The purpose of this SOP is to establish a standardized procedure for performing particulate matter testing in pharmaceutical products to ensure they meet quality standards and regulatory requirements.
2) Scope
This SOP applies to all pharmaceutical products that require particulate matter testing within the facility, including solutions, suspensions, and other injectables.
3) Responsibilities
3.1 Laboratory Analyst
– Conduct particulate matter tests as per this SOP.
– Document and report test results accurately.
3.2 Laboratory Supervisor
Ensure all testing procedures are followed.
Review and approve particulate matter test records.
3.3 Quality Assurance (QA) Personnel
Validate particulate matter testing methods.
Ensure compliance with regulatory guidelines.
4) Procedure
4.1 Preparation
4.1.1 Clean and disinfect the testing area and equipment.
4.1.2 Prepare test apparatus and reagents as specified in the test method.
4.2 Sampling
4.2.1 Collect samples aseptically to prevent contamination.
4.2.2 Transport samples to the testing area in sterile containers.
4.3 Testing Methods
4.3.1 Use light obscuration or microscopic particle count methods for particulate matter testing.
4.3.2 Prepare test samples according to the specified method.
4.3.3 Perform the test, ensuring proper calibration and operation of equipment.
4.4 Monitoring and Documentation
4.4.1 Monitor samples for particulate matter levels during the testing period.
4.4.2 Record observations and test results in the Particulate Matter Test Log.
4.5 Reporting
4.5.1 Compile test results and prepare a particulate matter test report.
4.5.2 Submit the report to QA for review and approval.
4.6 Investigation of Failures
4.6.1 Investigate any test failures to determine the source of particulate contamination.
4.6.2 Implement corrective actions to prevent recurrence.
5) Abbreviations, if any
– QA: Quality Assurance
6) Documents, if any
– Particulate Matter Test Log
– Particulate Matter Test Reports
– Calibration Records
7) Reference, if any
– United States Pharmacopeia (USP) <788> Particulate Matter in Injections
– European Pharmacopoeia (Ph. Eur.) 2.9.19 Particulate Contamination: Sub-visible Particles
8) SOP Version
Version 1.0