Standard Operating Procedure for Product Release Testing for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for conducting product release testing on aerosol products to ensure compliance with quality standards and regulatory requirements prior to distribution.
2) Scope
This SOP applies to product release testing performed on aerosol products manufactured by [Company Name] to verify product quality, safety, and efficacy prior to release for distribution and sale.
3) Responsibilities
Quality Control (QC) Team: Perform product release testing according to approved protocols and acceptance criteria.
Production Team: Provide aerosol products for testing and coordinate sample collection.
Regulatory Affairs: Review and approve product release 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 Preparation:
4.1.1 Collect representative samples of aerosol products from the final production batch.
4.1.2 Ensure samples are labeled and identified to maintain traceability throughout testing.
4.1.3 Equilibrate samples to specified storage conditions (e.g., room temperature) before testing.
4.2 Testing Parameters:
4.2.1 Define product release testing parameters based on product specifications and regulatory guidelines.
4.2.2 Determine testing methods and procedures for each attribute, such as appearance, container integrity, propellant content,
4.2.3 Ensure testing methods are validated and documented according to established protocols.
4.3 Testing Procedures:
4.3.1 Conduct visual inspection of aerosol containers for defects, leaks, and container integrity.
4.3.2 Perform propellant content determination to verify formulation consistency and stability.
4.3.3 Assess product performance through functionality testing, such as spray pattern evaluation and plume geometry assessment.
4.3.4 Record all observations and measurements during testing in designated test reports and data sheets.
4.4 Acceptance Criteria:
4.4.1 Establish acceptance criteria for each product attribute based on internal standards and regulatory requirements.
4.4.2 Compare test results against predefined acceptance criteria to determine product compliance.
4.4.3 Document pass/fail decisions and deviations encountered during testing.
4.5 Reporting and Documentation:
4.5.1 Prepare comprehensive product release 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 product release testing activities, including raw data, test protocols, and approval documentation.
4.6 Non-Conformance Handling:
4.6.1 Initiate non-conformance reports (NCRs) for aerosol products that fail product release testing, documenting reasons for failure and corrective actions taken.
4.6.2 Implement corrective actions to address identified issues, such as adjusting manufacturing processes or retesting.
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
Product Release Testing Protocol
Product Release Test Reports
Equipment Calibration Records
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO 9001: Quality management systems – Requirements
USP Chapter Aerosols – Product Release Testing Guidelines
8) SOP Version
Version 1.0