Standard Operating Procedure for Quality Control Testing of Aerosol Products
1) Purpose
The purpose of this SOP is to define the procedures for conducting quality control testing on aerosol products to ensure they meet regulatory requirements and internal quality standards.
2) Scope
This SOP applies to the Quality Control (QC) department at [Company Name], responsible for testing aerosol products at various stages of production and before release.
3) Responsibilities
QC Manager: Oversees all QC testing activities and ensures compliance.
QC Analysts: Perform tests and record results accurately.
Production Personnel: Provide samples and cooperate during testing procedures.
4) Procedure
4.1 Sampling:
4.1.1 Collect representative samples from each batch of aerosol products.
4.1.2 Ensure samples are labeled with batch number, date, and other relevant information.
4.2 Physical Tests:
4.2.1 Conduct tests for appearance, color, and clarity.
4.2.2 Measure fill weight and ensure it meets specified limits.
4.2.3 Perform leak testing using appropriate methods.
4.3 Chemical Tests:
4.3.1 Analyze the formulation for active ingredient content using validated methods.
4.3.2 Test for propellant content and ensure it is within acceptable limits.
4.3.3 Conduct pH testing and other chemical attributes as required.
4.4 Microbiological Tests:
4.4.1 Perform microbial limits testing to ensure product safety.
4.4.2 Conduct sterility testing for aseptic aerosol products.
4.5 Performance Testing:
4.5.1 Evaluate spray pattern, plume geometry, and spray force.
4.5.2 Assess content uniformity across samples.
4.6 Documentation:
4.6.1 Record all test results accurately in the QC test report.
4.6.2 Document any deviations or out-of-specification (OOS) results.
5) Abbreviations, if any
QC: Quality Control
OOS: Out of Specification
6) Documents, if any
QC Test Report
Batch Manufacturing Record (BMR)
7) Reference, if any
USP
8) SOP Version
Version 1.0