collection and use of human blood and plasma in the European Community in 1993

by Frances M. Delaney

Publisher: Directorate General Employment, Industrial Relations and Social Affairs, European Commission in Luxembourg

Written in English
Published: Downloads: 629
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Edition Notes

CEC/LUX/V/F/1/33/95.

Statementprepared by Frances M. Delaney for the European Commission.
ContributionsEuropean Commission. Directorate-General for Employment, Industrial Relations and Social Affairs.
ID Numbers
Open LibraryOL16267526M

Effect of the Plasticizer DEHP in Blood Collection Bags on Human Plasma Fraction Unbound Determination for AlphaAcid Glycoprotein (AAG) Binding Drugs Nicholas Ingram, Christopher Dishinger, Jennifer Wood, J. Matthew Hutzler, Sherri Smith, Michael Huskin AAPS J () 5. Human plasma contains the most comprehensive version of the human proteome. The complexity of the ‘plasma proteome’ is quickly understood when one considers all the various forms of blood plasma proteins present in plasma: precursor and mature forms, splice variants, degradation products and of course all combinations of posttranslational s: 2. S.I. No. of EUROPEAN COMMUNITIES (QUALITY AND SAFETY OF HUMAN BLOOD AND BLOOD COMPONENTS) REGULATIONS I, MARY HARNEY, Minister for Health and Children in exercise of the powers conferred on me by section 3 of the European Communities Act (No. 27 of ) and for the purpose of giving effect to Directive /98/EC 1 of the European Parliament and . Panel A shows whole blood and red cells; Panel B, plasma; Panel C, total platelets; and Panel D, the collection of autologous blood by hospitals. Bars represent the findings from surveys conducted.

In use, the inlet 9 is connected to a plasma supply source, which may supply plasma by gravity flow or under pressure, i.e., through use of a peristalic-type or plunger-type pump. Air is displaced through optional vent 15 and the plasma passes through the prefilter 29 and then through the hydrophilic microporous membranes 25 and Whole blood ( mL), plasma (– mL) and RBCs (about mL) were transfused over a 30–40 min period. Buffy-coat samples were gently re-suspended in a mL sterile pouch of isotonic (5%) glucose before administration over a 20–30 min period. Transfusion of the whole blood was performed within the 3 hours following blood collection. “ (ba) whole human blood and human blood components; ”. (d) In section , after subsection (5A) insert the following new subsection— “ (5B) For the purposes of this section, “human blood component” means any of the following constituents of human blood: red cells, white cells, platelets and plasma. ”. Blood plasma is a 'yellowish liquid' component of blood that holds the blood cells of whole blood in is the liquid part of the blood that carries cells and proteins throughout the body. It makes up about 55% of the body's total blood volume. It is the intravascular fluid part of extracellular fluid (all body fluid outside cells). It is mostly water (up to 95% by volume), and.

(a) The provisions of this subpart will apply to medicinal products for human or animal use, intermediates and starting materials (as referred to in the European Community (EC)) and to drugs for human or animal use, biological products for human use, and active pharmaceutical ingredients (as referred to in the United States), only to the extent. Blood is the fluid that sustains life. The components of blood include red blood cells, white blood cells, platelets, and plasma. Some blood cells carry oxygen (necessary for metabolic reactions), some blood cells fight off invading substances that could destroy your cells, and other blood cells help to form clots, which keep your body from losing too much blood. Human Blood Products LAMPIRE's Human Blood and Biological Products are collected from healthy donors. In addition to standard quality control tests, all donors of blood and blood derivatives are tested for HBsAg, HIV, HCV, and syphilis. Whole Blood is manually drawn from the donor and Source Plasma is collected by automated techniques. Four different blood collection tubes were tested on blood samples drawn from 5 volunteers; citrate, K 3-EDTA, and Lithium-heparin for plasma and serum from no-additive serum tubes. The following results were obtained (data are expressed as percent±SD of the value of the citrate tube): %±, %±, and ±% in the K 3 -EDTA.

collection and use of human blood and plasma in the European Community in 1993 by Frances M. Delaney Download PDF EPUB FB2

(3) The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or plasma were ensured through Directive /83/EC of the European Parliament and of the Council of 6 November on the Community code relating to medicinal products for human use(5).

The European Community’s rules on Good Manufacturing Practice (GMP) are set out in Commission Directive 91/ [1] which lays down the principles and guidelines of good manufacturing practice for medicinal products for human use.

As human blood and human blood products are “substances” within the meaning of Article 1(2) of Directive 65/65 Cited by: 1. When the development of blood component therapy was in its infancy countries were by and large self sufficient for whole blood.

Large scale export and import of plasma started in the s and early s, when both albumin and coagulation factor VIII became commercially available. The industry needed more and more plasma, and the development of plastic bags made plasmapheresis Cited by: pharmaceutical sector to produce plasma derivatives.

Blood and plasma derivatives can only be obtained from human donors making them a limited resource. At the European level, numerous initiatives related to the blood and plasma sectors have File Size: 2MB. Survey of blood transfusion services of central and eastern European countries and their co-operation with western transfusion services.

Council of Europe, The collection and use of human. (3) The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or plasma were ensured through Directive /83/EC of the European Parliament and of the Council of 6 November on the Community code relating to medicinal products for human use(5).

[15] F.M. Delaney, The collection and use of human blood and plasma in the European Community inBrussels: European Commission, (CEC/Lux/V/F/1/). 2 A book concerning organ transplantation containing all the Council of Europe states on plasma products and European self-sufficiency.

97 Recommendation No. R (93) 4 of the Committee of Ministers to member states on the use of human red blood cells for the preparation of oxygen.

Blood and blood components for transfusion are outside the scope of this Position Statement. Recommendations on the suitability of blood and plasma donors and the screening of donated blood in the European Community were described in Council Recommendation 98//EC.

This paper presents an organized system for element-specific sample collection and handling of human blood (whole blood, serum or plasma, packed cells or erythrocytes) and urine also indicating a proper definition of the subject and sample.

Harmonized procedures for collection, preparation, analysis and quality control are suggested. Community self-sufficiency in human blood and plasma through voluntary unpaid donations.

A repotr to the Council on the state of Community self-sufficiency resulted in it adopting Conclusions 3 in which the need to achieve this goal through cooperation between Member. Human Blood Plasma Proteins gives an overview of the proteins found in human blood plasma, with special emphasis on their structure and function and relationship to pathological states and disease.

Topics covered include: introduction to blood components and blood plasma proteins; blood plasma protein domains, motifs and repeats.

promotion of self-sufficiency of the European Community in human blood or human plasma through voluntary and non-remunerated donations. With regard to self-sufficiency, the Directive provides that: "Member States shall take the necessary measures to promote Community self-sufficiency in human blood or human plasma.

1. Introduction. The polemic between defenders of non-remunerated donation and those who uphold the need for paid donation is constantly resuscitated.1, 2It began after the publication by Titmuss of the book “The gift relationship.

From human blood to social policy”, which had a pivotal influence on changes in the seventies helping to convert the blood bank sector from paid to unpaid.

and efficiency (6). The plasma col-lected from these centers was called “source”, while the plasma obtained from whole blood was called “recov-ered plasma”. Outside the U.S., the supply of plasma remained mainly with the blood transfusion services. In Austria and Germany, legislation allowed more frequent donations.

"Labile blood products and plasma-derived products are very sensitive from a social viewpoint. Along with the challenges faced by all medicinal products there is an added challenge due to the lack of raw material and the social problems with regards to their acquisition.

Obtaining them depends on blood and plasma donations, which are insufficient. Recent European legislation has brought some aspects of transfusion practice under regulatory control, particularly with regard to the collection of plasma for fractionation.

For example, EEC Directive 89/ extended the scope of previous directives to include special provisions for medicinal products derived from human blood or human plasma. The report indicates that plasma collection for manufacturing has almost doubled between and going from eight and half to million litres collected, which has naturally affected the growth for plasma derivatives.

Unlike blood components for transfusion, plasma derivatives are considered as proper pharmaceutical products and have. - blood, plasma, RBC, WBC, platelets, plasma clotting factors, Indications: ↓ in blood volume anemia thrombocytopenia hemophilia Compatible transfusion ⇒ only the same group (A,B,0 and Rh) Universal donor (0) sal recipient (AB) (.

– revisited) Examination of blood prior transfusion 1) to determine blood groups - slide technique. (3) The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or plasma were ensured through Directive /83/EC of the European Parliament and of the Council of 6 November on the Community code relating to medicinal products for human use.

The specific exclusion of. However, the European Commission’s European Group on Ethics in Science and New Technologies has expressed an opinion on the mat although it dates from 12 th March, It is significant that the European Group decided to include plasma-derived products among the first issues they addressed: the document bears the number 2.

95 Collection centers. Plasma derived therapies; Manufacturing site in. Germany. - Urged review and modification “Blood Donation Law” - Use recovered plasma for fractionation.

from human blood or plasma were ensured through Directive /83/EC of the European Parliament and of the Council of 6 November on the Community code relating to medicinal products for human use (5). The specific exclusion of whole blood, plasma and blood cells of human origin from that Directive, however, has.

Results Stability. The stability of blood with respect to various laboratory analyses may be affected or controlled as follows (1, 2, 5, 6): (a) anticoagulants used in blood collection as described above; (b) stabilizing agents (e.g., EDTA and ascorbate) are necessary to preserve folates and vitamins and should be included in the collection device or added as soon as possible after collection.

The full text of this article hosted at is unavailable due to technical difficulties. Blood collection and preservation 1. COLLECTION &PRESERVATION OF BLOOD 2.

It is a blood collection used an all labs to find out why symptoms are appear in the patient Phlebotomy(“to cut a vein” in Greek) is the process of making incision in a vein.

A person who practices phlebotomy is termed as phlebotomist. The Collection and Preparation of Human Blood Plasma or Serum for Trace Element Analysis J. Versieck University of Ghent, De PintelaanB Ghent, Belgium Accepted: October 24 Trace element concentrations in blood plasma or serum have been assayed by numerous investigators using a variety of analytical techniques.

7 For the purposes of this book, the use of the term ‘blood system’ is intended to refer to the collection and supply of blood components; the manufacture and supply of plasma products; and policy and regulatory processes involved in these activities.

-Fresh Frozen Plasma. Fresh frozen plasma is collected, separated and stored frozen within 8 hours of collection. FF Plasma separated from whole blood by centrifugation approximately ml. (EDTA, CPD, CPDA1 or other, specify).-Component Plasma, Liquid or Frozen. Component plasma is obtained from red cells and for IVD reagent production.

The collection and use of human blood and plasma in the European community in European Commission document. CEC/LUX/V/F/1/33/95, Google Scholar; Costs apart, allogeneic red cell transfusion carries a well recognised potential for harm. Dodd RY. Opinion on Products Derived from Human Blood or Blood Plasma, Group of Advisers to the European Commission on the Ethical Implications of Biotechnology, Opinion No.

2 (Mar. 12, ) Principles for the Protection of Persons with Mental Illnesses and the Improvement of Mental Health Care, G.A. res. 46/, 46 U.N. GAORSupp.Art and photography books bring the vision of the world to your very eyes.

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