Points to Consider No. 15: Mobile Manufacturing

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This Points to Consider document aims to assess the feasibility and requirements for designing and qualifying a self-contained manufacturing process that, once validated, can be relocated and operated in a different location for the same process, without the requirement for regulatory preapproval or revalidation.The document includes exploring the technology supporting mobile manufacturing in greater detail and the regulatory requirements and risks associated with moving a manufacturing process from one location to another. While mobile manufacturing can be considered an enabling technology for distributed manufacturing or point-of-care manufacturing, the scope of this paper excludes identifying or elaborating on those requirements.