Abstract
Important parameters in plasma fractionation are derived from the needs of providing assured quality and the operational requirements of good manufacturing practice. There are many inputs to quality assurance, collectively described as the quality design of the manufacturing process. Quality design is an all-embracing concept depending on selection of source plasma, proper production facilities and equipment systems and highest pharmaceutical operational standards. The scientific process must meet the requirements of safety and efficacy of product and balance the competing parameters of purity, potency and yield within an acceptable economic framework. The paper illustrates problems within the theory of quality design through current experience in the production of immunoglobulin and factor VIII fractions.
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