To reduce time to market, the industry is putting out new products at a faster rate and outsourcing more activities than ever before. Time is of the essence. Therefore, technology transfer during product development, whether within and between companies, needs to work perfectly the first time, exceed expectations, and meet regulatory compliance. A quality technology transfer is just as important now (if not more so).
A critical component of success is demonstrating regulatory compliance. Accidents in chemical plants due to chemical labeling problems, lack of understanding of chemicals, or both, are more common than you might believe. Chemical, physical, and hazardous properties of a product must be well documented via proper labeling, documentation, packaging, provision of safe practices, and emergency response procedures.
For the granting organization to transfer production to a receiving organization with only a secrecy agreement or sales agreement and the manufacturing procedure is not acceptable. Technology transfer plans involve much more than that to ensure that the receiving organization can carry out a chemical process safely, on time, and within budget.
Thermal hazards must be fully characterized by the receiving organization. The granting organization may provide data from calorimetric evaluations, but ultimately the receiving organization must verify if the intended equipment is capable of carrying out the normal process and be able to relieve a worst-case scenario.
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