Articles by Louis A. Angelucci - Pharmaceutical Technology

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Articles by Louis A. Angelucci

Louis A. Angelucci


Louis A. Angelucci is the director of corporate validation at MedImmune, One MedImmune Way, Gaithersburg, MD 20878, tel. 301.398.2949.

Articles
Position Paper: Are We Abandoning IQ and OQ?
November 2, 2009
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The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of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."

Are We Abandoning IQ and OQ?
November 2, 2009
By: Louis A. Angelucci

New standards may overlook critical qualification needs.

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