
May/June 2013
Volume 33, Number 3
This issue presents a lead article on establishing and managing a vendor network for clinical supply manufacturing services; a QbD-focused interview with Roger Nosal, VP, Global Chemistry, Manufacturing and Controls (GCMC), Pfizer; an article on “eco-friendly” cleaning agents used in GMP applications; the last of a three-part series defining the facility of the future for biomanufacturing; an article on effective computerized system compliance through leveraging supplier effort; an article on the role of commissioning and qualification as part of the Process Validation Lifecycle described in the US FDA’s Guidance on Process Validation; and a comparison of process validation standards. Other features include global regulatory news and a message from ISPE’s President on how Members are making an impact on industry issues worldwide.
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