Getting it right from the start
From a regulatory perspective, a tech transfer of an aseptic commercial product between cleanrooms may not differ much regarding time and effort compared to the initial development and design of the manufacturing process. However, it is determined by multivariable aspects, including filing strategies, special arrangements with authorities, and the commitment to accepting potential operational and methodical changes that enable the achievement of state-of-the-art processes.
Given this high degree of complexity, getting it right from the start is critical. The first step is the creation of a dedicated team that includes experts from development, production, quality assurance, regulatory affairs, quality control, and qualification/validation. The team is responsible for facilitating and executing the process and coordinating with the technology transfer/project leader.
Because there are multiple partners and sites involved in every tech transfer, numerous development steps and challenges are necessary. These include the sending unit - where a designated product, process, or method is expected to be transferred from - and the receiving unit - where a designated product, process, or method is expected to be transferred and executed.