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Biopharmaceuticals from Plan to Production
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| By
Jim Fernandez
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Management of the product plan and details for biopharmaceutical production are included in an integrated review of biotechnology operations.
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Pfizer Outlines Its Supply Strategy
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| By
Patricia Van Arnum
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John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply, discusses the company's manufacturing and supply strategy and network.
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FDA/Industry Perspectives: Detection, Measurement, and Control in Manufacturing
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| By
Margeret M. Szymczak
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Richard L. Friedman
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Rajendra Uppoor
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Avraham Yacobi
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The authors summarize a recent FDA–PQRI workshop on process drift.
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PQRI Case Study (4): Process Deviation and Empty Product Capsules
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| By
Ted Frank
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Stephen Brooks
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Kristin Murray
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Steve Reich
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Ed Sanchez
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Brian Hasselbalch
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Kwame Obeng
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Richard Creekmore
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This risk-management case study focuses on assessing empty capsules.
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The Matrixx Zicam Verdict
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| By
Cathy Burgess
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Sean Simmons
,
Lynn D. Torbeck
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The authors summarize the Matrixx Initiatives, Inc. v. Siracusano case's implications for industry.
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Quality Issues for Multiregional Clinical-Trial Materials
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| By
Dennis Sandell
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Terrence Tougas
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Dennis O'Connor
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Steve Horhota
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The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.
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Assessment of Large-Sample Unit-Dose Uniformity Tests
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| By
Yanhui Hu
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David LeBlond
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The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.
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Applying Dry Powder Coatings
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| By
Matthew P. Mullarney
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Lauren E. Beach
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Beth A. Langdon
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Mark A. Polizzi
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The authors experiment with a resonant acoustic mixer as a method for dry powder coating.
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Time is of the Essence
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| By
Control, a senior compliance officer
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Letting contamination build up can cause multiple headaches.
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In the Spotlight
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New product reviews for October 2011 focusing on analytical instrumentation.
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OOS, OOT, OOC, and OOSC
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| By
Lynn D. Torbeck
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Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.
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Sustainability Outside the Box
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| By
Hallie Forcinio
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Drugmakers and packagers are pursuing various initiatives to reduce their carbon footprints. This article contains bonus material.
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Sizing Up the Global Market for Excipients
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| By
Patricia Van Arnum
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The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.
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