Saturday, 16 February 2013

GMP Review: Microbiology Laboratories

The current issue of the GMP Review contains an article titled “Good Practices for Pharmaceutical Microbiology Laboratories”. The article is a critical review of the 2011 WHO document on this important subject. The article has been written by Tim Sandle.

An extract from the article reads:

“The WHO document has a relatively narrow scope in terms of the perceived activities of a pharmaceutical microbiology laboratory and the scope is certainly inwards, in terms of the way a laboratory is run, rather than focusing outwards on the activities which laboratory staff might undertake. For example, the document is concerned with viable microbiological environmental monitoring within the laboratory but not with the activities of microbiology staff going into process areas to take airborne particle counts and to collect viable monitoring samples. This seems a little limited since the case for monitoring in an unclassified laboratory is somewhat debatable and the latter is something which occupies the time of many laboratory staff.”

The reference is:

Sandle, T. (2012) “Good Practices for Pharmaceutical Microbiology Laboratories”, GMP Review, Vol. 11, No.2, July 2012, pp12-14

To find out more about the GMP review go to the journal’s webpage here.

Posted by Tim Sandle