The Harmonization of the Microbial Limits Test - Absence of
Specified Organisms
Scott Sutton,
Ph.D.
Vectech
Pharmaceutical Consultants
This article first appeared in the
PMF Newsletter
of April, 2006 and is protected by copyright to PMF. It
appears here with permission.
The last issue of the PMF Newsletter (vol 12, no. 3)
contained a review of the harmonization status of the Microbial
Limits Tests – Enumeration. In addition, the article provided a
brief overview of the compendial harmonization process as agreed
to by the Pharmacopeial Discussion Group (PDG). In this article,
I would like to focus on the other side of the Microbial Limits
Tests – the “Absence of Specified Microorganisms” component.
|
USP |
EP |
|
<61> Microbiological Examination Of
Nonsterile Products: Microbial Enumeration Tests |
2.6.12 Microbiological Examination
Of Nonsterile Products: Microbial Enumeration Tests |
|
<62> Microbiological Examination of
Nonsterile Products: Tests for Specified Microorganisms |
2.6.13 Microbiological Examination
of Nonsterile Products: Tests for Specified
Microorganisms |
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<1111> Microbiological Quality of
Nonsterile Pharmaceutical Products |
5.1.4 Microbiological Quality of
Nonsterile Pharmaceutical Products |
Table 1: Harmonized Chapter
Numbering Scheme
There is a significant controversy in the United States over
the intent of this evaluation. The FDA is bound by the concern
expressed in the Code of Federal Regulations (21CFR 211.113 and
21CFR 211.165) relating to the importance of “objectionable
microorganisms.” This is not the concern of the compendial
chapters. The controversy is worthy of discussion, but not the
topic of this review – it will be discussed in length in the
final of three articles on the harmonization of the microbial
limits tests to be published in next month’s newsletter.
What follows is a tabular presentation of the existing
“Microbial Limits – Absence of Specified Microorganisms” tests
from the current USP and Pharm Eur, as well as the draft
harmonized document (the finalized document is extremely close
to this version, but not release to the industry). It is
provided as an aid to evaluation, and may assist in determining
whether revalidation of method suitability studies is needed. It
should be noted that this harmonization draft represents a true
compromise by all parties, with (at least in the author’s
opinion) significant changes from the current USP, Pharm Eur and
JP chapters.
Note: Due to it's extreme length,
Table 2 is
provided here as a .pdf file from the
PMF
Newsletter article
References
- EP. 2006. 2.6.13 Microbiological Examination of
Non-Sterile Products (Test for Specified Micro-Organisms).
Pharm Eur. 5.0:156-161
- USP. 2003. <62> Microbiological Examination of
Nonsterile Products: Tests for Specified Microorganisms
Pharm Forum. 29(5):1722-1733
- USP. 2006. <61> Microbial Limits Tests USP
29:2503-2508
Consulting with Scott Sutton
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