Quality control programme for the preparation of small-pool lyophilized heat-treated cryoprecipitates.

International and national documents on and standards for quality control have been introduced for Blood Banks. Recently, the Standard Registration Document and a National Health Authority Licence for factor VIII preparations based on the Document were introduced in the Netherlands. In the course of developing a preparation of lyophilized heat-treated cryoprecipitates in our Blood Bank, we used this Standard Registration Document and the good pharmaceutical manufacturing practices to design a quality control protocol. The aim of this protocol was to provide documented evidence on the quality of both our product and the production process. The protocol included the validation or revalidation of individual installations and procedures used during production, validation of the whole process and quality control of routine production. With our quality protocol we have been able to demonstrate that our preparation is consistently of the intended quality.