The arrangements made by the testing facility for the test substance towards complete lifecycle from its receiving to disposal are the responsibility of testing facility management. Records of environmental conditions during transportation must be available in the testing facility. Identification of the test substance at the receipt is an essential step towards assessing the integrity of test substance. Verification of test substance when received at the testing facility includes physical condition of the container upon arrival, confirmation of test substance as mentioned in supporting data or any other records that ensures the test substance integrity. The details pertaining of test substance that are required by testing facility to perform a GLP study which is also a requirement by EPA regulation. Presentation will also focus towards pitfalls where inadequate characterization details lead to study rejection. It will also highlight on role of sponsor towards sharing all the details of test substance that would assist in selecting dose, choosing carrier for toxicology study or performing method development or validation along with an extended rationale towards optimizing instrumental parameters. Information regarding stability of the test substance under storage conditions shall be available at the testing facility and if not , stability shall be determined. Reference substance and control shall be dealt similarly as that of test substance. The documentation pertaining to the test substance shall be archived and amount of test item to be archived shall be decided by the testing facility management. Disposal at the end of the study or after the archiving period shall be performed according to established procedures and should comply with national legislations for the disposal of chemicals and biological products.

EPA perspective towards test substance management in GLP testing facility

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.