Manufacturing Readiness & Technical Transfer

Manufacturing readiness and technical transfer activities support the transition from development to commercial manufacturing. Engineering plays a critical role in ensuring processes, equipment, and facilities are prepared to support compliant production.

Manufacturing readiness focuses on aligning engineering systems, documentation, and operational controls with GMP requirements. Technical transfer ensures knowledge, process parameters, and quality expectations are effectively communicated and implemented.

Well-executed readiness and transfer activities reduce startup delays and compliance risk.

Manufacturing readiness and technical transfer activities often include:

• Process and equipment readiness assessments

• Technical transfer planning and execution

• Engineering and manufacturing documentation review

• Facility and system readiness evaluation

• Support for initial production and scale-up