advanced and continuous pharmaceutical manufacturing
(1) Advanced and continuous pharmaceutical manufacturing The term “advanced and continuous pharmaceutical manufacturing” refers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods— (A) that incorporates a novel technology, or uses an established technique or technology in a new or innovative way, that enhances drug quality or improves the manufacturing process for a drug, including processes that may apply to advanced therapies and the production of biological products, such as cell and gene therapies; or (B) for which the input materials are continuously fed into and transformed within the process, and the output materials are continuously removed from the system, utilizing an integrated manufacturing process that consists of a series of 2 or more simultaneous unit operations.