Special Issues-07-01-2006

Special Issues

Analytical Instrument Qualification

July 01, 2006

Instrumentation

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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.

GMP and Phase I Clinical Trials: Streamlining the Critical Path?

July 01, 2006

Manufacturing

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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.

A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems

July 01, 2006

Instrumentation

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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.

FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief

July 01, 2006

Video

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Dr. Steven Galson, CDER Director, on Drug Risks, Regulation and Research

2006: A Regulatory Odyssey

July 01, 2006

Manufacturing

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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

July 01, 2006

Manufacturing

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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.

The Growing Regulatory Burden and Revolution in Global Clinical Trials

July 01, 2006

Clinical Trials

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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.

PAT Initiatives for QC/QA Operations: Enabling Paperless Processes for Manufacturing Batch Records and QC Laboratories

July 01, 2006

Manufacturing

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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.

The Sands of Time Cannot be Stilled

July 01, 2006

Manufacturing

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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.

Validation in the Chromatography and Spectroscopy Laboratories

July 01, 2006

Instrumentation

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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.

Party's Over

July 01, 2006

Marketing and Sales

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Pharmaceutical marketing and sales folks are now contending within creased government scrutiny of direct-to-consumer advertising and pharma-doctor relationships.