Standard Operating Procedure for Adhesive Residue Testing in Transdermal Patches
1) Purpose
To establish procedures for testing and measuring adhesive residue in transdermal patches to ensure product quality and patient safety.
2) Scope
This SOP applies to the quality control department responsible for conducting adhesive residue testing on transdermal patches during the manufacturing process.
3) Responsibilities
3.1 Quality Control Analyst: Perform adhesive residue testing according to defined procedures.
3.2 Production Supervisor: Ensure samples are provided for testing in a timely manner.
3.3 QA Personnel: Review and approve adhesive residue testing procedures and results.
3.4 Production Operators: Assist in sample preparation and handling during testing.
4) Procedure
4.1 Sample Collection:
4.1.1 Obtain representative samples of transdermal patches from production batches for testing.
4.1.2 Ensure samples are labeled with batch information and identification numbers.
4.2 Adhesive Residue Extraction:
4.2.1 Cut out adhesive portions of transdermal patches using validated techniques.
4.2.2 Extract adhesive residues using suitable solvents or extraction methods.
4.3 Quantitative Analysis:
4.3.1 Analyze extracted samples using validated analytical methods such as chromatography or spectroscopy.
4.3.2 Quantify adhesive residues based on established acceptance criteria and regulatory limits.
4.4 Reporting:
4.4.1 Record testing procedures, results, and observations in designated testing forms or laboratory notebooks.
4.4.2 Prepare test reports summarizing adhesive residue levels and compliance with specifications.
4.5 Documentation:
4.5.1 Maintain detailed records of adhesive residue testing activities, including raw data and calculations.
4.5.2 Archive test reports and related documentation for future reference and audits.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Adhesive Residue Testing Protocols
Test Reports
Batch Production Records
7) Reference, if any
USP General Chapter 1724: Adhesive Residue Testing in Transdermal Drug Delivery Systems
ICH Q3C(R6): Impurities: Guideline for Residual Solvents
8) SOP Version
Version 1.0
