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Bone marrow transplant is a potential cure for several diseases, including cancer and specific genetic disorders. Notably, this procedure is applicable for patients suffering from aplastic anemia, certain types of leukemia, severe combined immunodeficiency disease (SCID), Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, thalassemia, sickle-cell disease, and certain cancers.
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Considerations on the number of plasma donations per donor per year: Pro.

Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis·2025
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Challenges for Plasma-Derived Medicinal Products.

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Safety of Plasmapheresis in Donors with Low IgG Levels: Results of a Prospective, Controlled Multicentre Study.

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Reply to the Letter-to-the-Editor Comment to Moog et al.: Safety of Plasmapheresis in Donors with Low IgG Levels: Results of a Prospective, Controlled Multicentre Study.

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Induction of Graft-versus-host Disease and In Vivo T Cell Monitoring Using an MHC-matched Murine Model
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GMP in donor centres.

Rainer Moog1

  • 1Octapharma Plasma GmbH, Langenfeld, Germany.

Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis
|May 14, 2025
PubMed
Summary
This summary is machine-generated.

Implementing Good Manufacturing Practice (GMP) ensures donor and blood product safety. This review details GMP principles for quality management in blood collection and apheresis procedures.

Keywords:
Donor centreGood manufacturing practiceQualityQuality management

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Area of Science:

  • Blood banking and transfusion medicine
  • Regulatory affairs in healthcare
  • Quality management systems

Background:

  • Blood component collection and processing must adhere to established guidelines for donor safety and product quality.
  • Specific guidelines exist for blood collection, processing, and apheresis procedures.
  • Adherence to Good Manufacturing Practice (GMP) is mandatory for blood donor centers.

Purpose of the Study:

  • To review the principles of Good Manufacturing Practice (GMP).
  • To assess the impact of GMP on quality management within blood donor centers.
  • To provide practical guidance on managing GMP in blood collection and processing.

Main Methods:

  • Review of European GMP guidelines relevant to medicinal product manufacturing.
  • Analysis of GMP requirements for quality control, management, documentation, and manufacturing processes.
  • Examination of risk management strategies for identifying and mitigating production failures.

Main Results:

  • European GMP guidelines promote standardization in the production of medicinal products.
  • GMP outlines essential requirements for quality control, management, documentation, and manufacturing.
  • Risk management is a key component of GMP for identifying and quantifying production process failures.

Conclusions:

  • Implementation of Good Manufacturing Practice (GMP) is crucial for ensuring both donor and product safety.
  • GMP provides a framework for standardized and high-quality blood component production.