A technology transfer protocol is a formal document that outlines the procedures for transferring pharmaceutical manufacturing processes between facilities, ensuring product quality, efficacy, and safety are maintained.
Key Steps in the Technology Transfer Protocol:
Preparation
Define the transfer scope and objectives.
Identify responsible teams at both sending and receiving sites.
Documentation Review
Collect essential documents (batch records, SOPs, validation reports).
Review for gaps or discrepancies needing resolution.
Risk Assessment
Identify potential risks in the transfer.
Develop mitigation strategies.
Training
Train personnel at the receiving site on processes, equipment, and critical transfer elements.
Facility & Equipment Setup
Ensure necessary infrastructure and equipment readiness at the receiving site.
Make any required adjustments or calibrations.
Process Validation
Execute validation protocols to confirm process reliability and product quality.
Trial Batches
Produce initial batches to validate the transfer.
Evaluate these against predefined quality criteria.
Review & Approval
Analyze trial data, address deviations, and ensure consistency.
Completion & Reporting
Document transfer completion and prepare a report on the process and outcomes.
Post-Transfer Monitoring
Monitor production at the receiving site for a defined period to maintain quality and address any issues.
This streamlined protocol ensures a smooth and consistent transfer process across facilities.