Understanding of cleanroom-controlled environment static inspection requirements based on Good manufacturing practices for veterinary drugs (revised in 2020)

This paper reviews and compares the requirements of key parameters of cleanroom-controlled environment based on the two versions of Good manufacturing practices for veterinary drugs (2002 and 2020, respectively). Combined with the announcement No. 389 of the Ministry of Agriculture and Rural Affairs and the author’s on-site inspection experience, the key points and evaluation basis of cleanroom-controlled environment inspection in static state in the GMP 2020 for veterinary drugs are summarized, focusing on the new and key revised items of GMP 2020, such as the cleanliness (suspended particle concentration), sectional wind speed in the A-class area, air flow pattern, self-cleaning time, and integrity check of HEPA of supply air flow.