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Whatever Happened to Classical Chemistry?

November 2, 2009
By:David Vetterlein
Pharmaceutical Technology

A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.

Position Paper: Are We Abandoning IQ and OQ?

November 2, 2009
By:Louis A. Angelucci
Pharmaceutical Technology

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."

Building a Framework for Quality by Design

October 2, 2009
By:Ronald D. Snee
Pharmaceutical Technology

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

Packaging Goes Green

October 2, 2009
By:Hallie Forcinio
Pharmaceutical Technology

Pharmaceutical companies get ideas for sustainable packaging from other industries.

CROs and CMOs Go Further East

October 2, 2009
By:Angie Drakulich
Pharmaceutical Technology

Contract research organizations such as Covance are heading further east through Europe.

Standard-Setting Bodies Engage Russia

October 2, 2009
By:Angie Drakulich
Pharmaceutical Technology

As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.

How to Develop a Practical (and Compliant) Vendor Qualification Program

October 2, 2009
By:Nancy Cafmeyer, Jonathan M. Lewis
Pharmaceutical Technology

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.

Multinational Firms Stake Claims

October 2, 2009
By:Angie Drakulich
Pharmaceutical Technology

This article is part of a Special Report on the Emerging Markets of The East, October 2009

Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives

October 2, 2009
By:Angie Drakulich
Pharmaceutical Technology

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

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