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Quality Control Labs”, which is now a little out of date and was last revised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.
Posted by Tim Sandle
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