Blood, Blood Products, and Plasma - Quality, Safety and GMP Aspects

Blood, Blood Products, and Plasma - Quality, Safety and GMP Aspects

Vienna, Austria

Course No 16362


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

From Authorities:
Dr Dragoslav Domanovic, European Center for Disease Control
Dr Micha Nübling, World Health Organisation/Paul-Ehrlich Institut, Germany
Eva Lindberg, Swedish Medical Products Agency
Dr Karmin Saadat, AGES, Austria
Dr Frank Sielaff, Local GMP Inspectorate Darmstadt, Germany
From Science and Industry:
Svenja Barckhausen, Biotest
Dr Norbert Becker, KABS
Dr Stephan Kießig, VCC Medical
Dr Wolfgang Schumacher, SPC
Michael Szkutta, Octapharma
Dr Stephan Walsemann, KEDPLASMA
Aharon Weinstein, OrSense

Objectives

During this conference, speakers from authorities, industry, sciences and donation services provide you with information about the current developments and revisions of the regulatory requirements, e.g. for epidemiology, PMF and product quality . Furthermore, the developments in microbial safety – requirements and methods – will be introduced, e.g. residual risks of transmission of viral diseases. You will benefit from experts presenting their practical experiences and knowledge in the field of quality and safety of blood, blood products and plasma.
Other information provided during this course includes Donor Vigilance, quality requirements of plasma fractionators and preparative plasmapheresis issues.

Background

During the next years, blood donation services, plasma establishments and the plasma industry expect an increasing need of plasma for fractionation. Due to patient blood management and the decreasing recovered plasma this problem can be solved only by extension of plasmapheresis and increased procurement of source plasma in Europe and worldwide. Especially new indications of blood products – e.g. the use of IVIG in immunologic disorders – will cause a growth of plasma derived medicinal products. Against this background, the number of donations must be increased to ensure the patient centred care as well as the supply of the industry. The amount of imported plasma for fractionation between the European countries as well as from USA will also increase. The necessary base for a comprehensive and sufficient maintenance in the EU countries is a consistent and standardised level of quality and safety of blood and plasma donations.
Based on the regulations of the European Union, e.g.

  • Directive 2002/98/EC “Setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC”,
  • the “Plasma Master File”,
  • the European Pharmacopoeia or
  • the EDQM “Guide to the preparation, use and quality assurance of blood components”
integrative procedures for all countries are essential. Donor screening, microbial testing, donation practises and later on storage, distribution and look back systems should be on the same level in all member states.
Additionally, new guidelines and guideline drafts related to microbiological safety issues – like those related to HEV transmission or to classic GMP issues like process validation – have an impact on the field of blood and plasma products.

Target Group

This conference is designed for persons from

  • Donation services/Blood services
  • QA Staff
  • National and international Authorities
  • Plasma Fractionation
  • Control Laboratories
who are involved in regulatory affairs, quality assurance, quality control and manufacturing of blood , blood products or plasma

Programme

Mosquitoes as nuisance and vector species in Europe

  • Spread of exotic species like Aedes albopictus and in the view of climate change
  • Chikungunya and dengue fever are occurring on the European continent
  • Disease risk and control options
Current infectious threats to the blood safety in EU
  • Characteristics of donor derived infections
  • Epidemiology of transfusion-transmitted infection
  • Reported Infections among blood donors in the last years in the EU
  • Reported transfusion transmitted infections in the last years in the EU
Evaluation of Epidemiological Data
  • Evaluation
  • Analysis
  • Benchmarking
  • Comparing epidemiological date
  • Setting of acceptance limits
Plasma Quality vs. Volume
  • Extracorporeal volumes during plasmapheresis procedures
  • Compartments of interest during plasmapheresis
  • Metabolism of proteins, especially IgG
  • Impact of donation volumes and donation frequencies on the plasma quality and the donor safety
Hyperimmunization in Europe?
  • Hyperimmune products at the EU market
  • Hyperimmunization of plasma donors vs. selection of donors
  • Impact of the analytical assays
  • A list of wishes
WHO Guideline Residual Risk Calculation
  • Virus safety of blood components and of plasma products
  • Differential contribution of screening assay categories
  • Virus epidemiology of first time and repeat donors
  • Adjustment factors
Donor Safety – View from Plasma Source
  • Donation volumes
  • Donation frequencies
  • Lessons learned from studies for intensified plasmapheresis
Non-invasive Methods for Evaluation of Donor Acceptance
  • Principles of non-invasive measurements
  • Pre- and post-analytical errors with different methods
  • Experience with regulation
  • Pitfalls of the Hemoglobin measurement
EMA Plasma Master File certification procedure
  • Plasma master File (PMF) procedure
  • PMF data requirements
  • Data requirements for epidemiological data, monitoring change, alert limits
Quality Expectations – Inspectors View
  • Quality requirements
  • Industrial standards and their relevance
  • Inspections and inspection procedure
Quality Aspects on Contract Manufacturing
  • Applicable regulations
  • Expectations and requirements from an authority point of view
  • Realization phase and role as "consultant"
  • Practical hints
Data Integrity – Impacting Blood Products?!
  • QMS/PQS sections to be adjusted for Data Integrity
  • Critical steps in the collection and manufacturing processes
  • New “Critical Data” definition in the EU GPG (valid Feb. 2018)
  • DI assessment of computer systems
Interfaces in Plasma product manufacturing – Experience of an Inspector
  • Involved actors from plasma donation to distribution of finished product
  • GMP requirements for the involved parties
  • Deficiencies recently identified in GMP inspections
GDP relating to Transport and Storage of Plasma for Fractionation
  • GDP basics and the impact for plasma
  • Peculiarities of transportation
  • Peculiarities of storage

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