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European Biopharmaceutical Review
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The regulatory shift towards risk-based
quality management has been triggered
by the desire to provide a more balanced,
flexible, transparent, responsive and,
ultimately, a more predictable approach to
biopharmaceutical quality. This shift is
evident in numerous new guidance
documents, including:
- ICH Q8 guideline on pharmaceutical
development (including, for example,
Process Analytical Technology (PAT)
and Design Space) (1)
- ICH Q9 guideline on Quality Risk
Management (QRM) (2)
- ICH Q10 guidelines on the
Pharmaceutical Quality System (3)
The application of these approaches for
already licensed products has presented
manufacturers with the challenge
of implementing a new method of
pharmaceutical lifecycle management for
those products already approved via the
more outdated regulation through guidance.
A more realisable goal is the implementation
of the principles of risk-based management
to developmental products, where the more
classical approach of definition of the risk,
evaluating potential impacts and then
implementing measures to
control the risk, can follow
a clearer structure. With an
integrated approach to
QRM, principles for
risk management are
implemented throughout
the quality system,
and define a clear and
transparent approach
for dealing with risk.
This article provides a
foundational overview
of the principles of riskbased
management in
virus and prion safety,
and the contribution
of the various strategies
relating to risk
minimisation in the
final product.
QRM AND VIRUS SAFETY Effective risk management for virus
safety should be a transparent process
that enables appropriate decisions
regarding risk control |
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Andy Bailey has been actively involved in the pathogen safety of
biopharmaceuticals for over 13 years. Originally a biochemist, Andy
served for 9 years at the MRC Virology Unit in Glasgow, Scotland. In
1995, he moved, as Director of Virus Validation Services, to Q-One
Biotech Ltd, and then later to the Pathogen Safety group of Baxter
Healthcare in Vienna, Austria. Since 2005, Andy has been a
founder and CEO of ViruSure in Vienna, Austria. Over the last 10 years, Andy has
presented at numerous regulatory agencies either in support of products or as an
invited speaker at expert workshops, including the UK MHRA, German PEI, French
AFFSAPS, US FDA, EMEA and JMHLW (Japan). |
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Industry Events |
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PHASE II & IIa Clinical Trials
21-22 February 2012, Lancaster London Hotel, London
Learn how to overcome challenges in adapting the development process to achieve early Proof of Concept at Informa's 13th Annual Phase I & IIa Clinical Trials event.
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