Standard Operating Procedure for Clinical Trial Material Production for Creams
1) Purpose
The purpose of this SOP is to establish procedures for the production of clinical trial materials (CTMs) for creams. This ensures that CTMs are manufactured under controlled conditions, meeting regulatory requirements and maintaining product quality and consistency throughout the clinical trial phases.
2) Scope
This SOP applies to the Production Department and all personnel involved in the production of CTMs for creams. It covers the entire production process from receipt of materials to final release of CTMs for clinical trials.
3) Responsibilities
The Production Manager is responsible for overseeing and coordinating the production of CTMs. The Production Team and Quality Assurance (QA) team are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Receipt of Materials
4.1.1 Receive raw materials, packaging materials, and documentation required for CTM production.
4.1.2 Perform visual inspection and verification of materials against specifications and purchase orders.
4.1.3 Quarantine materials until release by QA.
4.2 Production Planning
4.2.1 Review the approved formulation and manufacturing instructions for CTM production.
4.2.2 Prepare a production schedule based on clinical trial requirements and resource availability.
4.2.3 Obtain approval from QA before initiating production.
4.3 Manufacturing
4.3.1 Prepare formulations according to approved procedures, ensuring accurate measurement
4.3.2 Monitor critical process parameters, such as mixing times, temperatures, and pH, throughout production.
4.3.3 Document all production activities, including deviations and corrective actions taken.
4.4 Packaging and Labeling
4.4.1 Package CTMs in accordance with clinical trial protocols and regulatory requirements.
4.4.2 Apply labels containing required information, including product name, strength, batch number, and expiration date.
4.4.3 Conduct in-process checks to verify correct packaging and labeling.
4.5 Quality Control Testing
4.5.1 Perform quality control testing on finished CTMs, including identity, strength, purity, and appearance.
4.5.2 Release CTMs for clinical use based on approved specifications and testing results.
4.5.3 Document all quality control testing procedures and results.
4.6 Documentation and Records
4.6.1 Maintain comprehensive documentation of all CTM production activities, including batch records, packaging records, labeling records, and quality control testing records.
4.6.2 Ensure that all CTM production records are retained according to the company’s document retention policy.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CTM: Clinical Trial Material
QA: Quality Assurance
6) Documents, if any
Approved Formulation and Manufacturing Instructions
Batch Production Records
Packaging and Labeling Records
Quality Control Testing Records
7) Reference, if any
ICH E6: Good Clinical Practice
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0