Monday, 10 February 2014

Good practices for Pharmaceutical Microbiology Laboratories



Tim Sandle’s review of ‘Good practices for Pharmaceutical Microbiology Laboratories’ was one of the top 5 most read articles on the GMP Logfile website.

As an introduction to his analysis, Dr. Sandle wrote:

“The Good Practices document has some similarities with the USP chapter <1117> “Microbiological Best Laboratory Practices” and together the two chapters are of importance given that there only other significant regulatory document is the FDA inspection guide “Microbiological Pharmaceutical Quality Control Labs”, which is now a little out of date and was last revised by the FDA in 1993. With regard to European GMPs and compendia there is no equivalent guidance or pharmacopoeial chapter.”

To view this article, go to GMP Logfile.

Note: the article was originally published in GMP REVIEW, VOL.11 NO.3 OCTOBER 2012.

Posted by Tim Sandle

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