Expiration Dating Of Chemicals And Reagents

Extract

With today's requirements for chemicals and reagents in research and clinical laboratory environments, questions often arise concerning expiration dating. Why are not all chemicals and reagents expiration dated by the manufacturer when they are made? How should expiration of chemicals and reagents not dated by the manufacturer be determined? How would a laboratory establish expiration of solutions and reagents prepared in-house?

To assure good manufacturing practices, many manufacturers comply with guidelines set for them by agencies such as the International Organization for Standardization (ISO) and are inspected by ISO auditors. Some manufacturers are required to comply with the Food and Drug Administration (FDA.) These manufacturers are known as GMP facilities (good manufacturing practices) and are assessed by FDA inspectors. Like regulatory agencies who govern clinical sites, ISO and FDA require manufacturers to establish uniform quality systems for product testing and certification.