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Related Experiment Videos

Good manufacturing practice and viral safety

B Kerner1

  • 1Octapharma, Pharmazeutika Produktionsgesellschaft mbH, Vienna, Austria.

Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis
|July 1, 1995
PubMed
Summary

Maintaining viral safety in blood product manufacturing requires strict adherence to Good Manufacturing Practice (GMP). This ensures products remain free from environmental recontamination after virus inactivation processes.

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Area of Science:

  • Biotechnology
  • Pharmaceutical Manufacturing
  • Public Health

Background:

  • Virus inactivation is critical in blood product manufacturing.
  • Potential for environmental recontamination poses a risk to product safety.

Purpose of the Study:

  • To outline essential elements of Good Manufacturing Practice (GMP) for preventing recontamination in blood product manufacturing.
  • To emphasize the importance of GMP in ensuring viral safety.

Main Methods:

  • Review of World Health Organization (WHO) GMP guidelines.
  • Identification of key GMP components relevant to environmental control and process monitoring.

Main Results:

  • GMP implementation requires clear organizational structure and trained personnel.

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  • Facilities, equipment, and supply systems must prevent recontamination of virus-inactivated materials.
  • Robust quality control and assurance systems are essential for process monitoring and overall performance review.

    • Conclusions:

    • Comprehensive commitment to non-negotiable GMP is fundamental for maintaining viral safety in blood products.
    • GMP serves as the cornerstone for preventing recontamination and ensuring product integrity.