Standard Operating Procedure for Clinical Trial Material Production for Transdermal Patches
1) Purpose
To establish procedures for the production of clinical trial materials (CTM) for transdermal patches, ensuring consistency, quality, and compliance with regulatory requirements during clinical trials.
2) Scope
This SOP applies to the production team responsible for manufacturing clinical trial materials (CTM), including production managers, operators, quality assurance (QA), and quality control (QC) personnel.
3) Responsibilities
3.1 Production Manager: Oversees CTM production and ensures adherence to SOPs and regulatory guidelines.
3.2 Operators: Execute manufacturing operations according to batch records and SOPs.
3.3 QA/QC: Verify compliance with quality standards through in-process checks and final product testing.
3.4 Regulatory Affairs: Ensures all CTM production activities are conducted in compliance with applicable regulatory requirements.
3.5 Project Manager: Coordinates timelines, resources, and documentation for CTM production.
4) Procedure
4.1 Material Preparation:
4.1.1 Ensure all raw materials and packaging components are qualified and released for use in CTM production.
4.1.2 Verify availability and accuracy of batch records and SOPs prior to starting production.
4.2 Manufacturing Process:
4.2.1 Follow approved batch records and SOPs to prepare and mix formulation components.
4.2.2 Apply formulation onto backing materials using validated manufacturing processes.
4.3 Packaging and Labeling:
4.3.1 Package CTM into unit dose containers or pouches according to specified packaging instructions.
4.3.2 Label each unit dose container or pouch with required information as per regulatory guidelines.
4.4 Quality Assurance and Control:
4.4.1 Perform in-process checks during manufacturing to ensure process parameters are within specified limits.
4.4.2 Collect samples for QC testing, including identity, strength, purity, and uniformity.
4.5 Documentation and Batch Release:
4.5.1 Document all CTM production activities, deviations, and corrective actions in batch records and associated documents.
4.5.2 Conduct final review and approval of batch records by QA prior to release for clinical trials.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CTM: Clinical Trial Material
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
Batch Records
Packaging Instructions
Labeling Specifications
7) Reference, if any
ICH E6: Good Clinical Practice
EU Guidelines to Good Manufacturing Practice: Annex 13, Investigational Medicinal Products
FDA Guidance for Industry: Preparation of Investigational New Drug Products (Human and Animal)
8) SOP Version
Version 1.0
