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Position Paper: Are We Abandoning IQ and OQ?
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| By
Louis A. Angelucci
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The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of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."
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Whatever Happened to Classical Chemistry?
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| By
David Vetterlein
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A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.
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Sharing Supply-Chain Security
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| By
Angie Drakulich
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A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.
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Facing Reality
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| By
Jim Miller
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Contract organizations waiting for the pipeline to come roaring back are kidding themselves.
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Changes for Better or Worse
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| By
Control, a senior compliance officer
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New tests solve one issue, but cheaper plastic and new stoppers cause problems.
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DIY Healthcare Reform
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| By
Michelle Hoffman
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While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.
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Report from: the Philippines
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| By
Jane Wan
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New pricing controls and healthcare reforms may be pushing the pharmaceutical market out of this southeast Asian country. This article contains bonus online-exclusive material.
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In the Spotlight
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Editors' Picks of Pharmaceutical Science & Technology Innovations
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