Special Issues, Jul 1, 2006 - Chromatography Online
Special Issues, Jul 1, 2006
Instrumentation
Validation in the Chromatography and Spectroscopy Laboratories
By 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.
Analytical Instrument Qualification
By Michael E. 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.
A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
By 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.
Validation in Biotechnology and Well-Characterized Biopharmaceutical Products
By Ira S. Krull , Michael E. 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.
Clinical Trials
The Growing Regulatory Burden and Revolution in Global Clinical Trials
By Tody Jane Hindin
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.
Clinical Trial Sponsors Face Growing Regulatory Burden
By Jill Wechsler
Safety and ethical concerns generate additional reporting and disclosure policies despite efforts to streamline research requirements.
European Clinical Trial Regulations Undergo a Slow Revolution
By Phillip Ward
Implementation of the EU Directive proves to be challenging as regulatory variations among member states continue and questions remain unanswered.
Good Clinical Practice Q&A
By Douglas R. Mackintosh , Vernette Molloy
Two experts in the GCP field answer common questions about clinical trials and regulatory compliance.
Better Compliance Through Technology
By Rob Davidson
In the clinical trials arena, integrated software solutions help life science companies meet ever more stringent compliance challenges.
Manufacturing
2006: A Regulatory Odyssey
By 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.
CDER?s Division of Post-Marketing Evaluation for Quality Assessment
By Eric P. Duffy , James Vidra , 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.
GMP and Phase I Clinical Trials: Streamlining the Critical Path?
By 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.
The Sands of Time Cannot be Stilled
By 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.
PAT Initiatives for QC/QA Operations: Enabling Paperless Processes for Manufacturing Batch Records and QC Laboratories
By John 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.
Keeping Pace
By Laura Bush
The world of manufacturing compliance is abuzz, and the rate of regulatory change has been evolving faster recently.
Moving Biotech Products from CBER to CDER: A Work in Progress
By Pamela Holland-Moritz
A slow, steady process of transitioning biologicals has allayed industry concerns.
Marketing and Sales
Party's Over
By Sara Calabro
Pharmaceutical marketing and sales folks are now contending within creased government scrutiny of direct-to-consumer advertising and pharma-doctor relationships.
Rated PG: Pharmaceutical Guidance Suggested
By 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?
New Climate
By 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.
Team Effort
By Ann Robert Brice
Brice Collaboration is replacing competitive edge when it comes to sales compliance training.
Video
FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief
Dr. Steven Galson, CDER Director, on Drug Risks, Regulation and Research

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