Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...
The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.
To meet the requirements of regulatory agencies, pharmaceutical products are produced in a controlled setting. One example of such a controlled environment is a cleanroom, which is used to minimize ...
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