Articles by Louis A. Angelucci - Pharmaceutical Technology

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Articles by Louis A. Angelucci

Are We Abandoning IQ and OQ?

New standards may overlook critical qualification needs.
Nov 2, 2009

New standards may overlook critical qualification needs.

Position Paper: Are We Abandoning IQ and OQ?

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of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."
Nov 2, 2009

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of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