Standard Operating Procedure for Label Inspection for Transdermal Patches
1) Purpose
To define procedures for inspecting labels used in the packaging of transdermal patches to ensure accuracy, consistency, and compliance with regulatory requirements.
2) Scope
This SOP applies to the quality control department responsible for inspecting labels during the packaging process of transdermal patches.
3) Responsibilities
3.1 Quality Control Inspector: Perform label inspections according to defined procedures.
3.2 Production Supervisor: Ensure labels are applied correctly and in accordance with approved artwork.
3.3 QA Personnel: Review and approve label inspection procedures and reports.
3.4 Regulatory Affairs: Ensure compliance with labeling regulations and requirements.
4) Procedure
4.1 Label Inspection Setup:
4.1.1 Verify the availability of correct label stock and artwork specifications.
4.1.2 Prepare inspection area with adequate lighting and magnification tools if necessary.
4.2 Inspection Process:
4.2.1 Retrieve labeled transdermal patches from the packaging line at predefined intervals.
4.2.2 Compare labels against the approved artwork and specifications.
4.2.3 Inspect for correct text, fonts, colors, barcodes, lot numbers, and expiration dates.
4.3 Defect Identification:
4.3.1 Identify and document any labeling defects or discrepancies.
4.3.2 Classify defects according to severity and impact on product quality and regulatory compliance.
4.4 Reconciliation:
4.4.1 Reconcile inspected labels with packaging records and batch documentation.
4.4.2 Verify that all required labeling information is present and legible.
4.5 Documentation:
4.5.1 Record inspection findings, including any deviations or non-conformities.
4.5.2 Maintain accurate and comprehensive documentation of label inspections.
4.6 Final Approval:
4.6.1 QA personnel review inspection reports and approve labels for use based on compliance with specifications.
4.6.2 Release inspected batches for further packaging and distribution.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Label Inspection Checklists
Label Inspection Reports
Batch Packaging Records
7) Reference, if any
FDA Code of Federal Regulations, Title 21 – Food and Drugs
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
