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Application Note: MicroNIR PAT for blend monitoring

18 January 2016 | By

The aim of Quality by Design (QbD) is to build quality into a product and process from the outset. The pharmaceutical and related industries utilise powder blending operations to make solid dose drugs, yet the phenomena of powder mixing is the least understood of all sciences.

article

PAT In-Depth Focus 2015

6 January 2016 | By

Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable...

article

Use of the ‘purge tool’ in assessing mutagenic impurities

6 January 2016 | By Dave Elder, GlaxoSmithKline and JPAG

The International Conference on Harmonization M7 text provides guidance on establishing acceptable levels of mutagenic impurities (MIs) . It also outlines the safety and quality risk management processes that manufacturers need to undertake to control MIs that may potentially affect the drug substance or drug product. Over the past decade,…