Standard Operating Procedure for Moisture Content Testing in Transdermal Patches
1) Purpose
To establish procedures for determining the moisture content in transdermal patches to ensure product stability and quality.
2) Scope
This SOP applies to the quality control department responsible for performing moisture content testing on transdermal patches during production.
3) Responsibilities
3.1 Quality Control Analyst: Perform moisture content 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 Preparation:
4.1.1 Obtain representative samples of transdermal patches from production batches.
4.1.2 Ensure samples are handled in controlled environmental conditions to prevent moisture absorption or loss.
4.2 Testing Method:
4.2.1 Determine the moisture content using validated analytical methods (e.g., Karl Fischer titration).
4.2.2 Calibrate and set up the moisture analyzer according to manufacturer’s instructions.
4.3 Data Analysis:
4.3.1 Perform moisture content analysis on prepared samples.
4.3.2 Calculate moisture content as a percentage based on weight loss or water content.
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 moisture content testing outcomes and compliance with specifications.
4.5 Documentation:
4.5.1 Maintain comprehensive records of moisture content 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
Moisture Content Testing Protocols
Test Reports
Batch Production Records
7) Reference, if any
USP General Chapter 921: Water Determination
ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
8) SOP Version
Version 1.0
