Learning Level: Intermediate -

The SARS-CoV-2 worldwide pandemic has presented a significant challenge to business continuity for pharmaceutical manufacturing. It has led to Industry re-assessing the virus control framework, and in particular, any challenges that this may present to the mitigations currently in place. This presentation will focus on the SARS-CoV-2 situation and factors to be assessed in a GMP Biopharmaceutical manufacturing facility and whether they present a secure virus mitigation strategy to protect the product from contamination from this and other viruses.

1. The factors involved in the virus control framework for a Biopharmaceutical manufacturing facility with reference to ICH Q5A. 
2. The planning activities required in order to prepare for a novel virus challenge to manufacturing facilities. 
3. Ongoing virus risk management and mitigations. 

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Speaker

Anne Stokes, PhD

Director TSE and Virus Control

GlaxoSmithKline

Thomas B. Hartman

President and CEO

ISPE