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