Reporting of Data
DIS/TSS-3 Jan 29, 1979
EFFICACY DATA REQUIREMENTS
Reporting of Data
Systematic and complete descriptions of the tests employed and the results
obtained are essential for proper review and evaluation of product performance
by the Agency. All test reports must include identification of the testing
laboratory or organization, when and where the tests were conducted, and
the name of the person(s) responsible for the conduct of the tests.
(1) Recommended Methods. When the Recommended Methods (such as
standard AOAC tests) are employed to develop efficacy data, certain minimal
information must be provided in the test report. The report must include,
but is not limited to, the following:
(a) Test employed, and any modifications thereto;
(b) Test microorganisms employed, including identification of the
specific strain (ATCC or other);
(c) Concentration or dilution of product tested and how prepared;
(d) Number of samples, batches, and replicates tested;
(e) Preparation date of each product batch (individually formulated
preparation of the product;
(f) Phenol resistance of test microorganisms (actual test results);
(g) Identification of all material or procedural options employed,
where such choice is permitted or recommended in the test method selected
(for example, growth media, drying time for inoculated carriers, neutralizer
and/or subculture media, secondary subculturing);
(h) Complete report of results obtained for each individual replication;
(i) Any control data essential to establish the validity of the test.
(2) Modification of Recommended Methods. Where Recommended Methods
are significantly modified to support specific claims and/or use patterns
for a product, the protocol employed for modifying the test must be provided
in specific detail with the test report. The applicant may submit the
proposed modification for review and evaluation prior to initiation of
the test.
(3) Other Methods. When Recommended Methods, or modification
thereto, are not employed to develop efficacy data (such as actual in-use
or many kinds of simulated-use testing), complete testing protocols must
be submitted with the test reports. All materials and procedures employed
in testing must be described in a manner consistent with original research
reports published in technical or scientific journals. Where references
to published reports or papers are made, copies or reprints of such references
should be provided with the test reports. Proposed testing protocols for
in-use or simulated-use studies of this kind may be submitted for review
and evaluation by the Agency prior to initiation of the tests.
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