Standard Operating Procedure for Finished Product Testing for Aerosols
1) Purpose
The purpose of this SOP is to outline procedures for conducting finished product testing on aerosol products to ensure compliance with quality specifications and regulatory standards before release for distribution.
2) Scope
This SOP applies to finished product testing performed on aerosol products manufactured by [Company Name] to verify product quality, safety, and efficacy prior to market release.
3) Responsibilities
Quality Control (QC) Team: Perform finished product testing according to approved protocols and acceptance criteria.
Production Team: Provide finished aerosol products for testing and coordinate sample collection.
Regulatory Affairs: Review and approve finished product testing protocols to ensure compliance with regulatory requirements.
Quality Assurance (QA) Team: Oversee adherence to SOPs and ensure documentation accuracy and completeness.
4) Procedure
4.1 Sample Collection and Identification:
4.1.1 Collect representative samples of finished aerosol products from the final production batch.
4.1.2 Label each sample with unique identifiers to maintain traceability throughout testing.
4.1.3 Store samples under specified conditions (e.g., room temperature) prior to testing.
4.2 Physical Inspection:
4.2.1 Inspect aerosol containers for defects, leaks, and overall appearance according to visual inspection criteria.
4.2.2 Verify container integrity and functionality, including valve operation and spray pattern.
4.2.3 Record all observations and findings during physical inspection in designated test records.
4.3 Chemical Testing:
4.3.1 Perform chemical tests to assess formulation integrity and stability, including assay of active ingredients and propellant content determination.
4.3.2 Conduct preservative content testing to verify efficacy and compliance with specified limits.
4.3.3 Document all analytical procedures, methods, and results in test reports and data sheets.
4.4 Microbiological Testing:
4.4.1 Conduct microbiological testing to evaluate microbial limits, ensuring compliance with pharmacopeial standards (e.g., USP, EP).
4.4.2 Perform sterility testing for aseptic aerosol products to confirm absence of viable microorganisms.
4.4.3 Record test methodologies, results, and interpretations in microbiological test reports.
4.5 Performance Testing:
4.5.1 Assess product performance through functionality testing, including spray force measurement and plume geometry evaluation.
4.5.2 Conduct propellant leakage testing to ensure integrity and stability of aerosol formulation.
4.5.3 Document performance testing procedures and results in comprehensive test reports.
4.6 Acceptance Criteria:
4.6.1 Establish acceptance criteria for each testing parameter based on internal standards, product specifications, and regulatory requirements.
4.6.2 Compare test results against predefined acceptance criteria to determine product compliance.
4.6.3 Document pass/fail decisions and deviations encountered during testing.
4.7 Reporting and Documentation:
4.7.1 Prepare detailed finished product test reports summarizing testing methods, results, and conclusions.
4.7.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.7.3 Maintain records of all finished product testing activities, including raw data, test protocols, and approval documentation.
4.8 Non-Conformance Handling:
4.8.1 Initiate non-conformance reports (NCRs) for aerosol products that fail finished product testing, documenting reasons for failure and corrective actions taken.
4.8.2 Implement corrective actions to address identified issues, such as adjusting manufacturing processes or retesting.
4.8.3 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
Finished Product Testing Protocol
Finished Product Test Reports
Equipment Calibration Records
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
ICH Q2: Validation of Analytical Procedures
USP Chapter
ISO 13485: Medical devices – Quality management systems
8) SOP Version
Version 1.0
