Pharmaceutical products are produced to meet strict standards for effectiveness and quality. Every aspect of quality is assessed, taking into account the risks associated with the method of delivery ...

Clean rooms are enclosed spaces where manufacturers apply environmental controls to prevent contamination of the products, focusing primarily on limiting the concentration of particulates in the air.

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 ...