Quality control in the production of an immunoglobulin for intravenous use.

This paper briefly surveys the control measures and tests which are carried out before, during and after manufacture of an i.v. immunoglobulin in order to assure the quality of the preparation. The quality requirements are determined by both the standards expected by physicians and patients and by the specifications of the registration authorities in the various countries. A great deal of know-how and considerable technical investment is required to match these requirements. Furthermore a comprehensive quality assurance programme is compulsory: It begins with the careful collection and analysis of each single blood donation, continues through all the manufacturing stages and ends with the rigorous testing of every batch of the end product - an examination comprising 23 different tests.