Designing facilities for aseptic filling

摘要

Following the updated GMP guidance implemented by the Chinese State Food and Drug Administration (SFDA) in March 2011, the People's Republic of China implemented a new version of its Good Manufacturing Practice (GMP) standard, now called China GMP 2010. The previous version, China GMP 1998, applied cleanliness grades set out by the US FDA. However, China GMP 2010 completely adopts the EU GMP cleanliness standards and the "in operation" classification was introduced. Therefore annex 1, on the manufacture of sterile medicinal products, led to a new challenge.