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.
- 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:
- Test employed, and any modifications thereto;
- Test microorganisms employed, including identification of the specific strain (ATCC or other);
- Concentration or dilution of product tested and how prepared;
- Number of samples, batches, and replicates tested;
- Preparation date of each product batch (individually formulated preparation of the product;
- Phenol resistance of test microorganisms (actual test results);
- 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);
- Complete report of results obtained for each individual replication;
- Any control data essential to establish the validity of the test.
- 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.
- 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.