Receipt reference substances

Receipt and storage of test substances and reference substances... 

Upon receipt of the reference substance at the field site, one must document the following name and source of reference substance the date of shipment and receipt the condition at receipt (e.g., seal broken or not, reference substance frozen, cold, or ambient when received) the lot number expiration date total amount received and storage requirements. A log should be kept in the field which documents the usage of the reference substance. The lot or reference number, date used, how much used, how much left, and the disposition of the reference substance should be recorded. 

Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference substances. 

Where necessary, the date of receipt of any substance used fortesting operations (e.g., reagents and reference standards) should be indicated on the container. Instructions for use and storage should be followed. In certain cases it may be necessary to carry out an identification test and/or other testing of reagent materials upon receipt or before use. 

GLPs require that there are separate areas for test, reference, and control substance receipt and storage, mixing with carrier, and storage of the mixtures. Test, reference and control substances are typically supplied by the sponsor and shipped directly to the field sites to be stored under label conditions. A computerized temperature and relative humidity monitoring device can be packaged with the test chemical prior to shipment, then down-loaded upon arrival to assure that the chemical was not subjected to conditions outside its stability range. 

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