Standard Operating Procedure for Foreign Particulate Matter Testing in Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the detection and identification of foreign particulate matter in aerosol products to ensure product quality and safety.
2) Scope
This SOP applies to foreign particulate matter testing conducted on aerosol products manufactured by [Company Name] to assess cleanliness and compliance with regulatory standards.
3) Responsibilities
Quality Control (QC) Team: Perform foreign particulate matter testing according to approved protocols and acceptance criteria.
Production Team: Provide aerosol samples for testing and coordinate sample collection.
Regulatory Affairs: Review and approve foreign particulate matter testing protocols to ensure compliance with regulatory guidelines.
Quality Assurance (QA) Team: Oversee adherence to SOPs and ensure documentation accuracy and completeness.
4) Procedure
4.1 Sample Collection and Preparation:
4.1.1 Collect representative samples of aerosol products from the final production batch.
4.1.2 Inspect aerosol samples visually for any visible foreign particulate matter under appropriate lighting conditions.
4.1.3 Prepare samples according to testing protocols, ensuring preservation of sample integrity and preventing contamination.
4.2 Microscopic Examination:
4.2.1 Prepare microscope slides or other suitable platforms for microscopic examination of aerosol samples.
4.2.2 Place prepared samples under the microscope and conduct visual inspection at various magnifications to detect foreign particulate matter.
4.2.3 Document findings including size, shape, color, and characteristics of any detected particulate matter.
4.3 Identification and Classification:
4.3.1 Use appropriate reference materials, standards, or databases to aid in the identification of detected foreign particulate matter.
4.3.2 Classify identified particulate matter based on composition (e.g., glass, metal, fibers) and potential source (e.g., packaging materials, manufacturing equipment).
4.3.3 Record and document all findings, including images, descriptions, and measurements of foreign particulate matter.
4.4 Acceptance Criteria:
4.4.1 Establish acceptance criteria for foreign particulate matter based on regulatory guidelines and product specifications.
4.4.2 Compare test results against predefined acceptance criteria to determine compliance.
4.4.3 Record and document all test results, including raw data, observations, and interpretations.
4.5 Reporting and Documentation:
4.5.1 Prepare detailed foreign particulate matter test reports summarizing testing methods, results, and conclusions.
4.5.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.5.3 Maintain records of all foreign particulate matter testing activities, including sample preparation, microscopic examination, and approval documentation.
4.6 Non-Conformance Handling:
4.6.1 Initiate non-conformance reports (NCRs) for aerosol products that fail foreign particulate matter testing or exceed acceptance criteria.
4.6.2 Investigate root causes of non-conformance and implement corrective actions to prevent recurrence.
4.6.3 Verify effectiveness of corrective actions through retesting and document outcomes accordingly.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
NCR: Non-Conformance Report
6) Documents, if any
Foreign Particulate Matter Testing Protocol
Foreign Particulate Matter Test Reports
Microscopic Examination Records
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
USP Chapter
ISO 14644: Cleanrooms and associated controlled environments
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
