Standard Operating Procedure for Uniformity of Dosage Units in Transdermal Patches

1) Purpose

To establish procedures for testing the uniformity of dosage units in transdermal patches to ensure consistency in drug content and adherence to quality standards.

2) Scope

This SOP applies to the quality control department responsible for performing uniformity of dosage units testing on transdermal patches during production.

3) Responsibilities

3.1 Quality Control Analyst: Perform uniformity 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 Production Operators: Assist in sample collection and preparation for testing.

4) Procedure

4.1 Sample Collection:

4.1.1 Collect representative samples of transdermal patches from production batches based on sampling plan.

4.1.2 Ensure samples are labeled with batch information and identification numbers.

4.2 Testing Method:

4.2.1 Prepare transdermal patches for testing by cutting into appropriate units or sections.

4.2.2 Perform assay or content uniformity testing using validated analytical methods.

4.3 Data Analysis:

4.3.1 Analyze test results to determine the uniformity of drug content across dosage