Terminology of Technology Transfer (TT)

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.