A
copy of Tim Sandle’ article ‘Good practices for Pharmaceutical Microbiology
Laboratories A review of the WHO Guidance’ has been published on line by the
site GMP Logfile. The article can be read on-line.
Here
is an extract:
“The
document is useful, however, in stating the need for supervision and for
authorised personnel for the release of results from the laboratory. The
document also outlines some of the basic training required for staff including
aseptic technique, serial dilutions, working with hazardous cultures, and
colony counting. Although there is not a great deal of detail, the section is
important because common agreement, nationally or internationally, on
microbiology laboratory training is lacking.
The
second substantive section concerns laboratory premises. In this part reference
is made to the need for dedicated areas for laboratory equipment, layout for
operations, the separation of laboratories from production areas, and
controlled access to microbiology areas. Reference is also made to cleaning and
disinfection of the laboratory, spillage policy and hand sanitisation.”
Posted by Tim Sandle
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