IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

Pharmaceuticals: What is Holding Back Quality By Design?

June 15, 2009 | Girish Malhotra

We come across many TLAs and their number is increasing. What is a TLA? It stands for “three letter acronym”. In the regulatory world, TLAs keep us on our toes. In the pharmaceutical world two TLAs are in vogue. They are QBA and QBD. Everyone associated with the manufacture of pharmaceuticals is familiar with these acronyms. But just to re-iterate, QBA is product “Quality By Analysis” and QBD is “Quality By Design”. QBA is the current tradition of the pharmaceutical manufacturing processes whereas QBD presents what the...

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