Search results for " document management system"

Article Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer. Jun 01, 2015 By Cynthia A. Challener BioPharm Inte…

Article Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …

Article Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies. By Jill Wechsler Frequent revisions and updates in manufacturing processes and operations are routine…

Article Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems. By Jerold M. Martin Single-use technologies (SUT) have made significant inroads in …

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 State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality? The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…

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 Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption. By Feliza Mirasol ARTMOIS/STOCK.ADOBE.COM Biopharmaceutical manufactu…

Article Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015 By Jill Wechsler BioPharm International Volume 28, Issue 6 The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…

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