Procedure for Drug Content Uniformity in Topical Patches
1) Purpose
The purpose of this SOP is to outline the procedure for testing drug content uniformity in topical patches to ensure consistent dosage delivery.
2) Scope
This SOP applies to all topical patches requiring drug content uniformity testing as part of quality control measures to assess product performance and adherence to specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing drug content uniformity testing.
Quality Assurance (QA) Department: Responsible for review and approval of drug content uniformity testing procedures and results.
Manufacturing Department: Responsible for providing topical patch samples and support during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Cut topical patch samples into standardized sizes as per specifications.
4.1.2 Ensure samples are representative of the entire batch and free from visible defects.
4.2 Test Setup:
4.2.1 Remove the backing layer to expose the adhesive surface of the topical patch.
4.2.2 Place each patch sample on a clean, dry surface suitable for analysis.
4.3 Drug Extraction:
4.3.1 Extract drug content from each patch sample using an appropriate solvent or extraction method.
4.3.2 Ensure extraction conditions are optimized to maximize drug recovery and consistency.
4.4 Analysis:
4.4.1 Analyze extracted samples using validated analytical methods (e.g.,
4.4.2 Quantify drug content in each sample and calculate the average drug content per patch.
4.5 Uniformity Assessment:
4.5.1 Evaluate drug content uniformity across multiple patch samples from the same batch.
4.5.2 Calculate the relative standard deviation (RSD) of drug content to determine uniformity.
4.5.3 Compare results against acceptance criteria and specifications.
4.6 Reproducibility Testing:
4.6.1 Repeat drug content uniformity testing on additional patch samples to confirm consistency.
4.6.2 Ensure agreement in drug content measurements across multiple tests.
4.7 Reporting:
4.7.1 Prepare a Drug Content Uniformity Testing Report summarizing test procedures, results, and conclusions.
4.7.2 Include any corrective actions or recommendations based on drug content uniformity testing findings.
4.7.3 Submit the report to QA for review and approval and maintain records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Drug Content Uniformity Testing Report
Analytical Data
Sample Testing Records
7) Reference, if any
USP (insert appropriate reference for topical patches)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0
