The Quality Lowdown: Novartis/Sandoz Child-Resistant Packaging; Solvent Testing; Quality Metrics; Cell And Gene Therapy

10 Jul 2018

Why did Novartis/Sandoz’s hospital blister packs have to be child-resistant? Why did two warning letters to Chinese firms follow promises of more, better testing? And should firms should consider volunteering for new FDA quality metrics programs (or not) and a pre-competitive industry collaboration on cell and gene therapies?

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It’s worth reviewing how Novartis Pharmaceuticals Corp. and its generic drug unit Sandoz Inc. responded to a single packaging incident that made one thing clear: tablets manufactured for use in hospitals can wind up in homes, and therefore must have child-resistant packaging.

Also worth a look: how two Chinese firms responded to US FDA inspections in ways that triggered warning letters. One,...