Articles by Duncan Low - BioPharm International

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Articles by Duncan Low

Managing Raw Materials in the QbD Paradigm, Part 2: Risk Assessment and Communication

Evaluate and communicate risk to stakeholders.
Dec 1, 2010
By: Anurag S. Rathore, PhD, Duncan Low

Evaluate and communicate risk to stakeholders.

Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks

An initial assessment of materials must extend beyond the material specification to include the supplier's manufacturing process, quality systems, and sourcing strategy.
Nov 1, 2010
By: Anurag S. Rathore, PhD, Duncan Low

Adequate characterization of materials protects product quality.