31 August - 3 September 2021
GMP News No. 787
7 September 2006
New USP Chapter for the Pharmaceutical Microbiology
This chapter summarises all activities necessary to manage a microbiological lab according to Good Laboratory Practices.
This GLP is different from the GLP addressing e.g. pre-clinical studies. The new USP chapter addresses labs working under GMP conditions.
It specifically mentions that, due to the known variances of microbiological results, fulfilling the requirements is extremely important.
In particular the chapter covers
According to the authors, the reasons making an interpretation of microbiological study results difficult are:
Discussions during audits and inspections especially with regard to the last item are most likely well known to everybody involved in microbiological quality control.
Altogether the chapter provides a good practice oriented overview over working in microbiological labs according to GMP.
European Compliance Academy (ECA) offers the following events on
Webinar: Harmonisation of EP, USP and JP The Impact on Microbiological
Contamination - Corrective Actions, Preventive Actions