Standard Operating Procedure for Technology Transfer in Creams Production
1) Purpose
The purpose of this SOP is to establish a systematic process for the transfer of technology from Research and Development (R&D) to manufacturing in creams production. This ensures that the knowledge, processes, and methods developed during R&D are effectively transferred to production while maintaining product quality and compliance.
2) Scope
This SOP applies to the R&D department, production department, and all personnel involved in the technology transfer process. It covers the transfer of new formulations, processes, analytical methods, and documentation from R&D to production.
3) Responsibilities
The R&D Manager is responsible for initiating and overseeing the technology transfer process. The Production Manager is responsible for receiving and implementing the transferred technology in production. Both R&D and production personnel are responsible for ensuring compliance with this SOP.
4) Procedure
4.1 Initiation of Technology Transfer
4.1.1 R&D initiates the technology transfer process by preparing a Technology Transfer Plan (TTP) that includes a detailed description of the technology, critical process parameters, quality attributes, and regulatory requirements.
4.1.2 The TTP is reviewed and approved by both R&D and production management before initiation.
4.2 Documentation Preparation
4.2.1 R&D prepares comprehensive documentation related to the technology transfer, including formulation records, process development reports, analytical method validation reports, and any other relevant documents.
4.2.2 Ensure that all documentation is complete, accurate, and aligned with regulatory requirements.
4.3 Training
4.3.1 Conduct training sessions for production personnel involved in the technology transfer process. Training should cover new formulations, processes, analytical methods, and quality expectations.
4.3.2 Document all training activities and ensure personnel competence before proceeding with technology transfer.
4.4 Transfer Execution
4.4.1 R&D and production teams collaborate closely during the transfer phase to ensure smooth implementation of new technology.
4.4.2 Transfer critical process parameters and quality attributes, ensuring alignment with R&D specifications.
4.4.3 Monitor and document the transfer process, including any adjustments made to ensure product quality and process efficiency.
4.5 Process Validation
4.5.1 Perform process validation studies to confirm that the transferred technology produces consistent and high-quality products.
4.5.2 Document process validation protocols, results, and any corrective actions taken during validation.
4.6 Stability Testing
4.6.1 Conduct stability studies on products manufactured using the transferred technology to verify shelf-life and storage conditions.
4.6.2 Monitor and document stability study results to ensure product quality over time.
4.7 Review and Approval
4.7.1 Review all documentation related to the technology transfer process, including formulation records, process documentation, validation reports, and stability data.
4.7.2 Obtain approval from R&D and production management before full-scale production using the transferred technology.
4.8 Documentation and Records
4.8.1 Maintain comprehensive records of the entire technology transfer process, including the Technology Transfer Plan, documentation preparation, training records, transfer execution, process validation, stability testing, and approval documents.
4.8.2 Ensure that all technology transfer records are retained according to the company’s document retention policy.
5) Abbreviations, if any
R&D: Research and Development
SOP: Standard Operating Procedure
6) Documents, if any
Technology Transfer Plan (TTP)
Formulation Records
Process Development Reports
Analytical Method Validation Reports
Training Records
Process Validation Protocols and Reports
Stability Study Reports
Approval Documents
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Process Validation
8) SOP Version
Version 1.0