Abstract
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 that 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.
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References
Messori A, Longo G, Matucci M, Morfini M, Gerrini PLR. Clinical pharmacokinetics of factor VIII in patients with classical haemophilia. Clin Pharmacokinet 1987;13:365–80.
Longo M, Matucci M, Morfini M, Vannini S, Messori A. A calculator program for individualizing factor VIII dosage. Drug Intell Clin Pharm 1984;18:726–30.
Anonymous. European Pharmacopoeia. 2nd ed. Part 1: V.2.1.5. Sainte Ruffine: Maissonneuve, 1980.
Anonymous. Anti-A and anti-B haemagglutinins. European Pharmacopoeia. 2nd ed. Part 2: VIII.5. Sainte Ruffine: Maisonneuve, 1980.
Rock GA, Tittley P. The effect of temperature variations on cryoprecipitate. Transfusion 1977;19:86–9.
Anonymous. International Forum. What are the critical factors in the production and quality control of frozen plasma intended for direct transfusion or for fractionation to provide medically needed labile coagulation factors? Vox Sang 1983;44:246–59.
Carlebjörk G, Blombäck M, Pihlstedt P. Freezing of plasma and recovery of factor VIII. Transfusion 1986;26:159–62.
Vermeer C, Soute BAM, Ate G, Brummelhuis HGJ. Contributions to the optimal use of human blood. Vox Sang 1976;30:1–22.
Allersma DP, Roeffen E, Van der Does JA, Briët E. Preparation of lyophilized heat-treated cryoprecipitates for a small pool of plasma obtained by apheresis. Pharm Weekbl [Sci] 1991;13:18–23.
Alain JP, Verroust F, Soulier JP.In vitro andin vivo characterization of factor VIII preparations. Vox Sang 1980;38:68–90.
Anonymous. Medi/Ware—Pharm. Groningen: University of Groningen/Mediware, 1987.
Gornall AG, Bardawill CJ, David MM. Determination of serum protein by means of the biuret reaction. J Biol Chem 1949;177:751–66.
Clauss A. Gerinnungsphysiologische Schnellmethode zur Bestimmung des Fibrinogens. Acta Haematol 1957;17:237–46.
Fischer K. Neues verfahren zur massanalytischen Bestimmung der Wassergehaltes von Flussigkeiten und festen Körpern. Angew Chem 1935;48:294–6.
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Allersma, D.P., Swüste, F., Briët, E. et al. Quality control programme for the preparation of small-pool lyophilized heat-treated cryoprecipitates. Pharmaceutisch Weekblad Scientific Edition 13, 24–31 (1991). https://doi.org/10.1007/BF01963880
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DOI: https://doi.org/10.1007/BF01963880