Understanding these terms is essential for clear and effective communication during technology transfer.
Technology Transfer (TT)
The systematic procedure that controls the transfer of any process, including documentation and expertise, between development and manufacturing units or between different manufacturing sites.
Sending Unit (SU)
The originating unit that provides the technology to be transferred.
Receiving Unit (RU)
The destination unit that receives and implements the transferred technology.
Transfer Protocol
A documented plan that outlines the transfer process, responsibilities, and acceptance criteria for successful technology transfer.
Transfer Report
A documented summary of all transfer activities, results, and any deviations encountered during the process.
Validation
The documented act of demonstrating that a procedure, process, or activity consistently produces the desired, reproducible results.
Qualification
The process of verifying that equipment operates correctly and delivers expected results.
Process Analytical Technology (PAT)
A system for designing, analyzing, and controlling manufacturing processes through real-time, in-process measurements to ensure quality.
Quality Risk Management (QRM)
A systematic approach to assessing, controlling, communicating, and reviewing risks that could affect the quality of the drug product.
Good Manufacturing Practices (GMP)
Guidelines that ensure products are consistently produced and controlled according to established quality standards.