Articles by Kevin O'Donnell - Pharmaceutical Technology

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Articles by Kevin O'Donnell

A New Risk-based GMP Inspection Planning Tool

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections. The tool is contained within a PIC/S document titled, "A Recommended Model for Risk-Based Inspection Planning in the GMP Environment," which was published in Dec. 2011 and became effective on Jan. 1, 2012 (1). This article describes the history behind the new methodology.
Nov 2, 2012

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections.

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