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The Quality Lowdown: A Week Of International Intrigue

ICH quality agenda, US FDA NDC code limits and fake API identity papers

 
• By Bowman Cox

Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.

Global strategy solution concept - earth jigsaw puzzle

An international consensus to pursue several quality-related initiatives proposed by the US pharmaceutical industry was disclosed last week, with the International Conference on Harmonization endorsing a new approach to advancing pharmaceutical quality standards.

Meanwhile, as drug makers prepare for the possibility of a rocky departure of the UK from the EU next year, the relevant authorities are talking about how they will smooth...

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