The WHO Expert Committee on Specifications for Pharmaceutical Preparations
adopted in 2009 a revised version of the Good practices for pharmaceutical
quality control laboratories. During the inspections carried out when
prequalifying laboratories, the inspectors had noticed that some of the texts of
these guidelines might benefit from additional guidance, with a special focus on
microbiology. In light of the above, the Expert Committee recommended that the
WHO Secretariat initiate the process of developing a new text on good practices for
pharmaceutical microbiology laboratories...