Commissioning and qualification of process equipment for the manufacturing of advanced therapy medicinal products

Abstract

The medical industry is highly regulated and monitored, but this has not always been the case. Current regulations are the result of countless deaths and injuries caused by poor-quality medical products. Validation is a concept that evolved during the development of this new regulation. The goal of validation is to establish proof that, following a validated, written procedure, the final product will meet all required specifications. By accomplishing this, it is possible to consistently manufacture high-quality products without excessive testing to ensure that all intermediate steps and the final product are within expected specifications. Commissioning and qualification (C&Q) are ways to create documented evidence that the equipment used as a part of a validated manufacturing process is working as intended and capable of consistently producing a high-quality product. This is a multi-step process with varying levels of complexity and formality based on the impact and risk the equipment has on the quality of the end product. The objective of this thesis was to follow the commissioning and qualification of new process equipment procured for FinVector’s new production facility. During this, the process is examined for inefficiencies to hopefully optimize the commissioning and qualification for future projects. Some inefficiencies were discovered and discussed with potential solutions. Communication between teams and departments, as well as robust knowledge management, were found to be of great importance to increase the efficiency of the C&Q process. Additionally, a well-thought-out C&Q process that is considered right from the start when planning a new facility was found to be a key concept.