Search results for "business continuity management"

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
By Beth H. Junker. Beth H. Junker is the senior director of fermentation and development operations at Merck Research Laboratories ABSTRACT The aim of this paper is to de…

Article Robust Business Continuity Program Helps to Maintain Operations in the Face of Crisis
As we began 2020, no one could have foreseen that just a few weeks into the year, we would be facing a pandemic threatening unprecedented damage to human health and the world economy. Businesses are…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Article Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry. By Jennifer Markarian  The implementation of singl…

Article Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain. Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…

Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Quality by design for biotechnology products—part 3
Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals. By Taruna Arora, …

Article The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture. By Andrew Harrison, Susan J. Schniepp The long awaited, anxio…

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

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