A proposal for installation, operaticon, and performance qualification protocol for hot cells for radiopharmaceuticals production
Background: According to the International Organization for Standardization (ISO), "quality assurance" is an all planned and systematic set of actions that are necessary to guarantee that a product or service will satisfy the requirements as to quality. As such, it is comprehensive and covers all relevant procedures, activities, and actions. This article aims to present a proposal for a checklist to be performed in the installation, operation and performance qualification for hotcells in agreement with the relevant standards recommendations.