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| Position Paper: Are We Abandoning IQ and OQ?
| | | By
Louis A. Angelucci
| | | The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of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."
| | | Whatever Happened to Classical Chemistry?
| | | By
David Vetterlein
| | | A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.
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| Sharing Supply-Chain Security
| | | By
Angie Drakulich
| | | 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
| | | By
Jim Miller
| | | Contract organizations waiting for the pipeline to come roaring back are kidding themselves.
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| Changes for Better or Worse
| | | By
Control, a senior compliance officer
| | | New tests solve one issue, but cheaper plastic and new stoppers cause problems.
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| DIY Healthcare Reform
| | | By
Michelle Hoffman
| | | 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
| | | By
Jane Wan
| | | 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
| | | Editors' Picks of Pharmaceutical Science & Technology Innovations
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