The People’s Republic of China recently switched from US to EU GMP guidelines. A hypothetical facility was designed in an academic exercise by students* that provides an example of how the Chinese are looking to implement the guidelines.
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.1 Therefore annex 1, on the manufacture of sterile medicinal products, led to a new challenge.
The aim of this project was to design a facility for the aseptic production of the powdered beta-lactam broad-spectrum antibiotic cefuroxime sodium that would:
- Mitigate any contamination risk
- Offer the most simple and effective workflow for material and staff
- Meet specific cleanroom classification standards
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