Besides the technical challenge related to the adaptation of the manufacturing process, the management of regulatory activities is one of the most challenging and also potentially disruptive for a complex technology transfer. This is mainly because any delay in the approval path from the Health Authority will lead to a delay in the supply of the product and consequently, to a potential shortage of the medicinal product on the market. Therefore, Regulatory and Supply Chain activities are deeply linked and proper planning of the submission, along with a sharp analysis of the changes and the specific regulatory requirements in certain areas, represent the key factors for a successful Technology Transfer.
To develop a strong transfer strategy, the planning phase can be considered the most delicate phase. A deep analysis of the gap assessment must be considered the base to understanding the extent of the impact, and consequently to evaluate the possible approval timelines of the variations submitted and the required supporting documentation in compliance with the applicable requirements.
Moreover, in different geographical areas the same changes could require different regulatory approaches so a “cluster methodology” or a “wave” strategy should be considered to minimize potential impacts on a global scale of differences in approval timelines and/or documentation requests. These differences should also be evaluated in the light of a specific cross-analysis with the market forecast supply, since bringing stock can be built to avoid product stock-outs.
Even though it is not always feasible, such as in the case of short notice site closures, the technology transfer process is intended as a long path in which an early start of activities and strong planning are decisive factors to minimize the market impact.
The presence of a global coordination, particularly for regulatory activities, is essential, as is the involvement of local regulatory experts who know the real practices, followed by the local Health Authorities.
Supply functions should also be involved in early phases to properly plan the shutdown of the sending manufacturing plant, assuring the product won’t be missed from the market until the new manufacturing site is fully operative.
