Standard Operating Procedure for Label Inspection for Aerosols
1) Purpose
The purpose of this SOP is to define procedures for the inspection of labels applied to aerosol products to ensure accuracy, compliance with regulatory requirements, and product quality.
2) Scope
This SOP applies to the inspection of labels for aerosol products at [Company Name], including but not limited to primary product labels, secondary packaging labels, and regulatory labeling requirements.
3) Responsibilities
Quality Control (QC) Team: Perform label inspection and verification activities.
Production Team: Apply labels to aerosol products according to approved specifications.
Quality Assurance (QA) Team: Oversee compliance with label inspection procedures and regulatory requirements.
Regulatory Affairs: Review and approve label specifications and labeling changes.
4) Procedure
4.1 Label Inspection Setup:
4.1.1 Verify label specifications, including text, layout, color, and regulatory information.
4.1.2 Set up inspection equipment (e.g., visual inspection stations, barcode readers) as per SOPs.
4.1.3 Ensure adequate lighting and environmental conditions for accurate label inspection.
4.2 Label Inspection Process:
4.2.1 Inspect labels for accuracy, alignment, legibility, and adherence to approved specifications.
4.2.2 Use barcode readers or scanning devices to verify product codes and batch information.
4.2.3 Record inspection results, including any discrepancies or non-conformances identified during inspection.
4.3 Regulatory Compliance:
4.3.1 Ensure compliance
4.3.2 Review label content for mandatory regulatory information (e.g., warnings, precautions, ingredient lists).
4.3.3 Document and maintain records of label inspections and regulatory compliance for audit purposes.
4.4 Label Rejection and Disposition:
4.4.1 Identify labels that do not meet approved specifications or regulatory requirements.
4.4.2 Quarantine non-conforming labels and initiate corrective actions as per SOPs.
4.4.3 Document the disposition of rejected labels and ensure proper labeling of compliant products.
4.5 Documentation and Reporting:
4.5.1 Maintain records of label inspections, including inspection reports, inspection logs, and corrective action reports.
4.5.2 Prepare periodic reports summarizing label inspection activities, findings, and compliance status.
4.5.3 Review and approve label inspection records and reports by designated personnel to ensure accuracy and completeness.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
FDA: Food and Drug Administration
6) Documents, if any
Label Specifications
Label Inspection Records
Regulatory Compliance Documents
Corrective Action Reports
Approval Records and Documentation
7) Reference, if any
FDA Code of Federal Regulations Title 21
EMA Guidelines on Labeling
USP Chapter Labeling
8) SOP Version
Version 1.0