Standard Operating Procedure for Visual Inspection of Transdermal Patches
1) Purpose
To define procedures for visually inspecting transdermal patches to ensure they meet quality standards and specifications before release for packaging.
2) Scope
This SOP applies to the quality control department responsible for conducting visual inspections of transdermal patches during the production process.
3) Responsibilities
3.1 Quality Control Inspector: Perform visual inspections according to defined procedures.
3.2 Production Supervisor: Ensure transdermal patches are presented for inspection in a timely manner.
3.3 QA Personnel: Review and approve visual inspection procedures and reports.
3.4 Production Operators: Assist in preparing and handling transdermal patches during inspection.
4) Procedure
4.1 Preparation:
4.1.1 Verify availability of transdermal patches for inspection with correct batch documentation.
4.1.2 Prepare inspection area with adequate lighting and magnification tools if required.
4.2 Inspection Process:
4.2.1 Retrieve samples of transdermal patches from production at predefined intervals.
4.2.2 Examine each patch for visual defects such as discoloration, cracks, tears, or foreign particles.
4.2.3 Compare patches against approved specifications and artwork.
4.3 Defect Identification:
4.3.1 Document any defects found during inspection and classify them based on severity and impact on product quality.
4.3.2 Notify production personnel of any deviations from quality standards for immediate corrective action.
4.4 Re-inspection:
4.4.1 Re-inspect patches that have undergone rework or repair to ensure defects have been addressed.
4.4.2 Record re-inspection findings and obtain approval before releasing patches for further processing.
4.5 Documentation:
4.5.1 Maintain detailed records of visual inspection activities, including inspection reports, photographs of defects, and approvals.
4.5.2 Archive inspection records in accordance with document control procedures and regulatory requirements.
4.6 Final Approval:
4.6.1 QA personnel review inspection reports and approve patches for packaging based on compliance with specifications.
4.6.2 Release inspected batches for packaging and further processing.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Visual Inspection Checklists
Visual Inspection Reports
Batch Production Records
7) Reference, if any
USP General Chapter 905: Uniformity of Dosage Units
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0