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 units.
4.3.2 Calculate and compare drug content per unit against acceptance criteria specified in approved specifications.
4.4 Reporting:
4.4.1 Document testing procedures, results, and observations in designated test records or laboratory notebooks.
4.4.2 Prepare test reports summarizing uniformity testing outcomes and compliance with specifications.
4.5 Documentation:
4.5.1 Maintain comprehensive records of uniformity testing activities, including raw data and calculations.
4.5.2 Archive test reports and related documentation for review and audits as per document control procedures.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Uniformity Testing Protocols
Test Reports
Batch Production Records
7) Reference, if any
USP General Chapter 905: Uniformity of Dosage Units
ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
8) SOP Version
Version 1.0
