Fda expiration dating and stability testing for human drug products
A known hemophiliac patient, with a potent inhibitor to human factor VIII was bleeding uncontrollably, and all available porcine factor VIII in the pharmacy was out-of-date. Porcine blood product was the only effective treatment at the time for this clinical situation in which factor replacement with human material was pointless. Vigorous discussion ensued regarding the chances of lessened efficacy of the available vials. No one considered whether the product might prove toxic, but that was because the treating physicians were relatively ignorant about the processes of drug denaturation and production of degradants, and the risks from these processes.
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This guidance document is a revised version of the ICH Q1A R guidance document and defines the stability data package for a new drug substance or drug product. The changes made to the Q1A R guidance document are outlined in the accompanying covering note to this guidance document. In adopting this ICH guidance, Health Canada endorses the principles and practices described therein.
The information on this page is current as of April 1 The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications, except for sterility and pyrogen testing. The retention time is as follows:. The reserve sample shall be stored in the same immediate container-closure system in which the drug product is marketed or in one that has essentially the same characteristics. The reserve sample consists of at least twice the quantity necessary to perform all the required tests, except those for sterility and pyrogens.