US Pharmacopeia's General Information Chapter ‹1117› "Microbiological Best Laboratory Practices" is currently under revision after being in
effect since 2006. It currently stands as the only guidance document that covers the basics of running a microbiological laboratory
in the pharmaceutical industry. Scott Sutton is on USP's Committee of Experts, Microbiology and Sterility Assurance, and spoke
to Pharmaceutical Technology regarding the recent developments in this chapter.
PharmTech: Can you provide a brief background into the state of the industry that led USP into thinking a chapter on microbiology
laboratories was necessary?
Sutton: We had been talking about a chapter on microbiology laboratory practices since the 1990s. USP would get regular requests
from laboratories for clarification on how you should be performing certain activities, some of these activities very basic
to the laboratory functions. There was also a lot of interest in how to perform investigations and what is the best way to
do a variety of standard operations. It was pretty clear that the people that were functioning as managers and supervisors
and were heading-up the laboratory were asking very basic questions about how to perform microbiological testing. There were
just not enough, and still aren't, microbiologists to go around.
PharmTech: Which types of companies were asking these questions?
Sutton: Smaller companies in particular were asking for a lot more clarification in terms of a USP informational chapter. On the other hand, however, the larger companies were less enthusiastic about additional USP guidance
on this topic. For them, fewer regulations were better, which was an entirely understandable position. But that still left
most laboratories searching for answers and unsure of their practices during regulatory audits. Also, as a historical perspective,
at the same time these discussions were going on, there was a big push to harmonize sterility test and the antimicrobial efficacy
test. It was obvious that it was going to be a wasted effort if once these tests went out, laboratories employed questionable
PharmTech: Once the decision was made to get started on the chapter, what was the approach?
Sutton: We talked about the chapter for years as an interesting idea before actually trying to publish it, and circulated
several versions of a potential chapter among the committee before publication. Within the committee there was significant
concern about the issue of being too proscriptive while at the same time being relevant and "informational." The result was
what is admittedly a vague description of guiding principles for how you should run a quality control microbiology lab. We
published this as the first draft of the proposed new informational chapter (see Pharmaceutical Forum (PF)
29 (3), 842 ). It originally was released under the title of "good laboratory practices for microbiology." But because
of input from the agency, we amended the title to the current one and incorporated several comments from the field (see PF
30 (5), 1713 ).
For example, some of the comments said media was not important, and that we should consider dropping the media section of
the chapter. But that is wrong. Media is critical in a microbiology laboratory but this point was apparently not coming across
in the original and so the text was amended to try to clarify this. Other comments pointed out potential improvements in the
chapter and were incorporated. The point of the chapter was to focus people's attention on those aspects important to running
a well-controlled microbiology lab in a controlled manner, including media, culture, training, cleanliness, hygiene, and equipment.
And for that purpose, it has been an extremely successful chapter.
PharmTech: What has been the response to this chapter?
Sutton: The official chapter first appeared in USP's Supplement 2, in 2006. The response has been generally very positive, although it has been interesting to see how people are
applying it. For example, the PMFList (pharmaceutical microbiology forum) is an active online discussion group devoted to QC microbiology. Different aspects of
this chapter are regularly debated in this forum, and in fact some of these discussions directly influenced changes in the
chapter to be proposed in the upcoming proposed revisions to the chapter (due out in the March-April 2009 PF).