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8.2 CSL Behring’s 4-Step Integrated Safety System
The safety of plasma products has reached a high level as
a result of the introduction of innovative technologies for
the inactivation and removal of viruses and prions. Based
on current understanding, the commercially available
plasma factor and inhibitor concentrates pose minimal
risk, and there remains only a theoretical risk of trans-
mission of infectious diseases.
As shown in Figure 31, CSL Behring employs a 4-step
Integrated Safety System to help ensure the quality of its
plasma protein products, including:
•
Careful donor selection and rigorous screening
of donations
•
Advanced manufacturing processes
•
Implementation of thorough Quality Control
and Assurance
•
Monitoring of the commercial products.
Selection of donation centers
1.
Plasma Selection and
Donation Control
2.
Manufacturing
Processes
3.
Quality Control
4.
Monitoring of
Commercial Products
Exclusion of donors who pose risk
Medical investigation of donors
Serological testing of donations
NAT/PCR testing of donations
Removal and
inactivation of potential
contamination present
Reporting and
evaluation of adverse
drug reactions and
performance of
appropriate measures
Documentation
of use
Internal quality control
Official certificate
and batch release
Inventory hold of source plasma with
lookback procedure
Computer monitoring of plasma
selection
Reduction
of potential
contamination
Release of plasma pools for fractionation
Figure 31 – CSL Behring’s Integrated Safety System for Plasma Derivatives
From Donation to the Finished Commercial Product
NAT=Nucleic acid amplification technology; PCR=Polymerase chain reaction.
