Manufacturing and Production

Technology Transfer and Scale Up in Pharmaceutical Manufacturing

A process that works in development frequently fails on a production line, not because anything was done wrong but because scale changes mixing, heat transfer and shear in ways the small equipment never revealed. This course covers moving a product safely. Delegates work through what a transfer package must contain for a receiving site to succeed, including process understanding rather than only a procedure. Gap analysis between sending and receiving sites follows, covering equipment, utilities, materials and capability. Scale up principles are addressed for the unit operations that behave differently with size, particularly blending, granulation, drying and compression. Equipment differences and their process consequences are covered. Analytical method transfer is addressed with its own qualification. Demonstration and validation batches follow. Documentation, change control and regulatory notification are covered, since a transfer usually triggers a variation. Training and knowledge transfer to the receiving team are addressed. The course closes on post transfer monitoring and on the problems that surface only after routine production begins.