Validation in the Chromatography and Spectroscopy Laboratories
David Walsh
Validation is one of the most critical issues facing today’s chromatographers and spectroscopists. With developments in this area moving for-ward at a staggering pace, it is more critical than ever that scientists have the most up-to-date information possible on validation.
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Analytical Instrument Qualification
Michael Swartz
In the most general sense, validation refers to a process that consists of at least four distinct components or steps: software, instruments, methods or procedures, and system suitability.
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Validation in Biotechnology and Well-Characterized Biopharmaceutical Products
Ira S. Krull and Michael Swartz
This article describes the current situation in FDA-regulated areas, as well as characterization of these products. Finally,the author discusses the various stages of early- and late-phase product developments.
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A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
R.D. McDowall
The two questions to ask when considering the validation of computerized laboratory systems are “Do I need to validate the system?”and,if so,“How much work do I need to do?” This article provides a simple framework to answer these questions at the system level.
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The Growing Regulatory Burden and Revolution in Global Clinical Trials
Toby Jane Hindin, PhD
At the same time the pharmaceutical industry faces new and complex issues with the drug development process and clinical trial environment, regulatory policies are increasing and adding to the burden of cost and time to market.
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Clinical Trial Sponsors Face Growing Regulatory Burden
Jill Wechsler
Safety and ethical concerns generate additional reporting and disclosure policies despite efforts to streamline research requirements.
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European Clinical Trial Regulations Undergo a Slow Revolution
Philip Ward
Implementation of the EU Directive proves to be challenging as regulatory variations among member
states continue and questions remain unanswered.
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Good Clinical Practice Q&A
Douglas R. Mackintosh and Vernette J. Molloy
Two experts in the GCP field answer common questions about clinical trials and regulatory compliance.
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Better Compliance Through Technology
Rob Davidson
In the clinical trials arena, integrated software solutions help life science companies meet ever more stringent compliance challenges.
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2006: A Regulatory Odyssey
Douglas McCormick
The regulatory environment is changing and is starting to sweep away some of the commandments on which we have relied, and to change others almost unrecognizably. To make the transition, FDA will have to reinvent itself and industry will have to rethink the way we develop and manage our processes.
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CDER’s Division of Post-Marketing Evaluation for Quality Assessment
Eric P. Duffy, James D. Vidra and Hasmukh B. Patel
The new Division of Post Marketing Evaluation in the Office of New Drug Quality Assessment has implemented an improved system for managing the submission and review processes for post approval chemistry, manufacturing, and controls change supplements.
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GMP and Phase I Clinical Trials: Streamlining the Critical Path?
Gordon B. Richman
FDA is modernizing and streamlining the regulatory processes for product development. This article examines FDA's proposed rule to exempt the production of Phase 1 clinical trial materials from the GMP regulations and questions whether this proposed exemption will truly improve public health and promote faster and more predictable access to new medicines.
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The Sands of Time Cannot be Stilled
Juanita L. Fuge
The FDA has been implementing several changes in the way it does business, for example, relying on third-party inspections, academia, and industry in many new ways. The implementation of process analytical technology is among these changes.
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PAT Initiatives for QC/QA Operations: Enabling Paperless Processes for Manufacturing Batch Records and QC Laboratories
John P. Helfrich
This paper outlines the current situation in manufacturing and quality operations relative to industry compliance initiatives and manufacturing challenges. It profiles an innovative “method-centric” software platform, designed for the analyst or operator, to electronically execute and man-age quality control testing protocols and production batch records, yielding significant reductions in overall product release cycle time.
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Keeping Pace
Laura Bush
The world of manufacturing compliance is abuzz, and the rate of regulatory change has been evolving faster recently.
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Moving Biotech Products from CBER to CDER: A Work in Progress
Pamela Holland-Moritz
A slow, steady process of transitioning biologicals has allayed industry concerns.
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Party’s Over
Sara Calabro
Pharmaceutical marketing and sales folks are now contending within creased government scrutiny of direct-to-consumer advertising and pharma-doctor relationships.
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Rated PG: Pharmaceutical Guidance Suggested
Diane West
PhRMA and FDA are in agreement that direct-to-consumer advertising needs reform. The question is: What’s the best way to get it?
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New Climate
Sarah Houlton
Europe’s new advertising controls and efforts to institute anti-fraud measures are looking more and more like those in the United States.
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Team Effort
Ann Roberts
Brice Collaboration is replacing competitive edge when it comes to sales compliance training.
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