2. Regulations and standardization
Depending on their field of activity, users of cleanrooms are subject to regulations requiring them first and foremost to control contamination. The following standards and/or regulations are potentially applicable to them, depending on their activities (non-exhaustive list):
pharmaceutical Good Manufacturing Practices (GMP) ;
European medical device regulations (MDR 2017/745);
good preparation practices ;
good hospital pharmacy practice ;
the order of June 11, 2013 on the rules of good practice designed to guarantee biological safety and security;
the decree of July 16, 2007 setting out the technical preventive measures, in particular containment, to be implemented in research,...
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Regulations and standardization
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