Good manufacturing practice blood products

Blood transfusion is highly regulated worldwide by government institutions, such as the USFDA, and through associations of blood banks, such as the American Association of Blood Banks (AABB). Strict regulations on good manufacturing practices (GMP) have been estabhshed to ensure maximum safety of the transfused products. 

Use of ionizing radiation in the manufacture of medicinal products Good manufacturing practice for investigational medicinal products Manufacture of products derived from human blood or human plasma... 

Rigorous application of good manufacturing practice (GMP) with regard to the manufacture of blood products is required to minimize the risk of pathogen transmission. Most GMP or related guidelines contain sections that address issues particularly relevant to the production of blood products. The prevention of accidental pathogen transmission relies upon ... 

Glomeruli Network of tiny blood vessels in the kidneys where the blood is filtered and waste products are removed GLP Good laboratory practice GMP Good manufacturing practice... 

European Union requirements for blood establishments are to be found in the Guide to Good Manufacturing Practice for Medicinal Products ... 

Infectivity can be reduced by introducing good manufacturing practice (GMP), both in blood banks and in plasma fractionation units. The sterility of the final products is checked and virus inactivation measures (for example heat treatment and/or chemical inactivation) are taken whenever appropriate. At present, virus inactivation procedures are most relevant to non-cellular products, although leukodepletion procedures using filtration have been used for infectious agents that are almost exclusively intracellular. 

Since the quality of the final products is affected by all the steps in their manufacture, including the collection of blood or plasma, the collection of blood or plasma intended for the manufacture of derivatives should be considered as part of the manufacturing process and it should therefore be done with an appropriate system of Quality Assurance and the current Good Manufacturing Practice. 

NOTE The general chapters of the guide to Good Manufacturing Practice apply to products derived from human blood or plasma, unless otherwise stated. Some of the annexes may also apply, e.g., manufacture of sterile medicinal products, use of ionising radiation in the manufacture of medicinal products and the annex on biological medicinal products. 

For production of medicines, relevant annexes are clustered into good manufacturing practices (main principles and several categories of products e.g. active ingredients, excipients, blood products), risk analysis, technology transfer and training materials. 

---