Standard Operating Procedure for Application Site Testing for Transdermal Patches
1) Purpose
To establish procedures for conducting application site testing of transdermal patches to evaluate skin reactions and ensure product safety.
2) Scope
This SOP applies to the clinical research or quality control departments responsible for conducting application site testing during transdermal patch development or post-market surveillance.
3) Responsibilities
3.1 Clinical Researcher: Perform application site testing according to defined procedures.
3.2 Quality Control Analyst: Conduct testing as per protocol and report findings.
3.3 Medical Officer: Review and interpret clinical data to assess skin reactions.
3.4 Regulatory Affairs: Ensure compliance with regulatory requirements related to application site testing.
4) Procedure
4.1 Selection of Test Subjects:
4.1.1 Obtain informed consent from volunteers or patients participating in the study.
4.1.2 Screen subjects for suitability based on inclusion and exclusion criteria.
4.2 Application of Transdermal Patches:
4.2.1 Apply transdermal patches to designated skin sites according to study protocol.
4.2.2 Ensure patches are secured and monitored for the specified duration.
4.3 Observation and Assessment:
4.3.1 Monitor application sites for any signs of irritation, erythema, edema,
4.3.2 Assess and document skin reactions using standardized evaluation scales or criteria.
4.4 Data Recording and Reporting:
4.4.1 Record observations promptly and accurately in case report forms (CRFs) or electronic data capture (EDC) systems.
4.4.2 Report findings to the responsible personnel for review and further analysis.
4.5 Documentation:
4.5.1 Maintain detailed records of application site testing procedures, including participant demographics and test results.
4.5.2 Archive study documents and reports in accordance with regulatory requirements and document control procedures.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CRF: Case Report Form
EDC: Electronic Data Capture
6) Documents, if any
Application Site Testing Protocol
Clinical Study Reports
Regulatory Submission Documents
7) Reference, if any
ICH E6(R2): Good Clinical Practice
ISO 10993-10: Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Sensitization
8) SOP Version
Version 1.0
