Standard Operating Procedure for Active Ingredient Penetration Testing in Transdermal Patches

1) Purpose

To establish procedures for testing the penetration of active ingredients through the skin in transdermal patches to ensure efficacy and compliance with product specifications.

2) Scope

This SOP applies to the quality control department responsible for conducting active ingredient penetration testing during transdermal patch manufacturing.

3) Responsibilities

3.1 Quality Control Analyst: Perform penetration testing according to defined procedures.
3.2 Production Supervisor: Provide samples for testing in accordance with sampling plans.
3.3 QA Personnel: Review and approve testing procedures and results.
3.4 Research and Development: Provide support in developing and validating penetration testing methods.

4) Procedure

4.1 Sample Preparation:

4.1.1 Cut transdermal patches into appropriate sections or units for testing.

4.1.2 Ensure samples are identified with batch information and sampling details.

4.2 Testing Method:

4.2.1 Place transdermal patch samples on skin membrane models or suitable biological membranes.

4.2.2 Apply testing conditions such as temperature, humidity, and exposure time as per protocol.

4.3 Analysis of Penetration:

4.3.1 Collect samples after specified exposure periods and remove excess formulation.

4.3.2 Analyze