Standard Operating Procedure for Visual Inspection of Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the visual inspection of aerosol products to ensure product quality, integrity, and compliance with regulatory requirements.
2) Scope
This SOP applies to the visual inspection of aerosol products at [Company Name], including primary product inspection and secondary packaging inspection for visible defects.
3) Responsibilities
Quality Control (QC) Team: Perform visual inspections of aerosol products and packaging.
Production Team: Ensure proper handling and presentation of aerosol products for inspection.
Quality Assurance (QA) Team: Oversee compliance with visual inspection procedures and regulatory requirements.
Packaging Team: Verify secondary packaging for proper labeling and condition.
4) Procedure
4.1 Pre-Inspection Preparation:
4.1.1 Gather aerosol products and secondary packaging materials for inspection.
4.1.2 Set up inspection area with adequate lighting and visual inspection equipment as needed.
4.1.3 Verify inspection criteria and acceptance standards based on product specifications and regulatory requirements.
4.2 Primary Product Inspection:
4.2.1 Inspect aerosol cans or containers for dents, scratches, leaks, or other physical defects.
4.2.2 Check product labels for accuracy, legibility, and adherence to regulatory requirements.
4.2.3 Ensure product fill levels and visual appearance meet specified standards.
4.3 Secondary Packaging Inspection:
4.3.1 Examine secondary packaging (e.g., cartons, trays) for damage, labeling accuracy, and batch traceability.
4.3.2 Verify batch codes and expiration dates on secondary packaging materials.
4.3.3 Document any discrepancies or non-conformances observed during inspection.
4.4 Compliance and Documentation:
4.4.1 Record inspection results, including findings, observations, and any corrective actions taken.
4.4.2 Review and approve inspection records by designated personnel to ensure accuracy and completeness.
4.4.3 Maintain inspection documentation in accordance with regulatory requirements and company policies.
4.5 Training and Continuous Improvement:
4.5.1 Train personnel involved in visual inspection on SOPs, inspection techniques, and regulatory requirements.
4.5.2 Conduct periodic audits and reviews of visual inspection practices to identify opportunities for process improvement.
4.5.3 Implement corrective and preventive actions (CAPA) to address recurring issues and improve inspection effectiveness.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
6) Documents, if any
Visual Inspection Records
Training Records for Inspection Personnel
CAPA Reports
Approval Records and Documentation
7) Reference, if any
FDA Code of Federal Regulations Title 21
USP Chapter
Company-Specific Quality Standards and Specifications
8) SOP Version
Version 1.0
