Voices of Biotech
Podcast: MilliporeSigma says education vital to creating unbreakable chain for sustainability
MilliporeSigma discusses the importance of people, education, and the benefits of embracing discomfort to bolster sustainability efforts.
September 1, 2011
Many companies use risk assessments, yet their test protocols remain bloated and cumbersome, with a focus on protocol adherence rather than verification of system functionality. In the September 2011 issue, Peter Watler introduces the ASTM E 2500-07 international industry consensus standard for conducting risk-based design and qualification of GMP manufacturing systems.It uses risk- and science-based practices to focus on critical aspects affecting equipment systems throughout their design-qualification-operation lifecycle.This moves the process from a rigid, protocol-enforced accumulation of documentation to meaningful evaluation of system performance and output quality relating to products and patients.
Included here are larger versions of the example documents Watler provided in his article.
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