ABSTRACT
Need for Evaluation of the Lyophilized Product An evaluation of the final lyophilized product serves to characterize its various physical and chemical properties and the effect that the storage conditions will have on such properties. The evaluation of these properties is, without question, of paramount importance. However, the results of such evaluation should also provide insight as to what effect the initial formulation and the various steps in the lyophilization process may have had on the observed properties of the product. It is not merely a question of what the properties of the final product are but also their source. The relationship between the observed properties of the final product and the materials and the processes that were involved (as described in the previous chapters) can be evident only as a result of careful documentation of the analytical methods and their results. This documentation of the analytical methods and nature of the final product not only verifies batch-to-batch consistency but also provides a vital benchmark that can be an invaluable source of information should a significant change occur in the nature of the lyophilized product.
