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,