One of the requirements of ISO Guide 34 accredited reference material manufacturers is to perform comprehensive stability studies in order to ensure that the best products possible are available to customers. A stability study looks at many quality factors in an effort to determine how long the product will maintain its integrity once it is out of the controlled conditions of the laboratory. Ultimately, it allows the manufacturer to accurately determine shelf life. This short paper highlights the process ERA follows in determining a product shelf life and how expiration dates are selected and defended.
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