Yes, as with any new method people need to become familiar with it. <60> is
largely modeled on <62>.
USP <60> states under Indicative Properties:
Suitability of the Test Method
The ability of the test to detect Bcc in the presence of the product to be
tested must be established. The incubation time for the method suitability
should not exceed the shortest incubation period specified. Suitability
must be confirmed if there is a change in testing performance or a change
in the product that may affect the outcome of the test.
For each new product to be tested, perform the sample preparation as
described in *Testing of Products*. At the time of mixing, add each test
strain in the prescribed growth medium. Inoculate the test strains
individually. Use a number of microorganisms equivalent to NMT 100 cfu in
the inoculated test preparation.
Perform the test as described in *Testing of Products*, using the shortest
incubation period prescribed. Bcc microorganisms must be detected with the
indication reactions described in *Interpretation*.
As this section specifically refers to Bcc and instructs to use each test
strains separately you would use B. cepacia, B. cenocapacia and B.
multivorans as instructed in Table 2 for use for both growth-promotion and
indicative properties. S. aureus and P. aueruginosa is used to demonstrate
the inhibitory properties of the BCS agar.
On Wed, Jan 15, 2020 at 11:49 AM Robert Pritchett <
[log in to unmask]> wrote:
> Hello PMFList,
> As one of the early adopters of the new USP <60> test chapter, I have
> received possibly the first feedback from FDA about BCC data submitted to
> the agency since the chapter went effective December 1st, 2019 that I'll
> share with the group.
> The FDA reviewer is under the impression that all five microorganisms
> listed in USP <60> Table 1 are to be used in method suitability testing.
> There's the three Burkholderia species, but Table 1 also lists S. aureus
> and P. aeruginosa which are listed as inhibited microorganisms in USP <60>
> Table 2.
> I believe the reviewer is mistaken and this feedback most likely
> originates from the header of USP <60> Table 1 which is titled "Test
> Strains of Microorganisms for Growth Promotion AND Suitability Testing".
> Inhibited organisms are not used in suitability testing per the current
> USP <62> FAQ #12, so I would assume it is not required for USP <60> as
> well. For example, MacConkey broth is checked for S. aureus inhibition
> during media qualification, however S. aureus is not used in method
> suitability of the USP <62> E. coli test. I have contacted the USP liaison
> for chapter USP <60> (Dr. Radhakrishna Tirumalai) and confirmed the intent
> of Table 1 is to test BCSA for inhibition of S. aureus and P. aeruginosa
> during media qualification, not suitability.
> In our response to FDA, I have explained our position about not using S.
> aureus and P. aeruginosa in the BCC method suitability.
> If any other early adopters of USP <60> get similar feedback from FDA, I
> ask that you push back on the request so collectively we can make sure this
> does not become the industry standard for the BCC test.
> Best regards,
> Robert W. Pritchett
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