GMP Compliance of Clean Rooms

摘要

From the design of clean rooms to their daily operation, the manufacturing in clean rooms must comply with a variety of authority requirements and expectations. Most of them are usually summarized under the term "(current) Good Manufacturing Practice". Regarding these basic regulatory requirements for clean rooms, the concluding consequences for the feasibility of qualifications/validiations up to the daily monitoring of clean rooms are explained using the aseptic filling of sterile liquid drug products as an example.