The Hindu Business Line : Build quality into drugs: US expert

In the context of growing concern about quality of drugs in the US, drug manufacturers should build quality into product without excessive reliance on testing methods, according to Dr Rodd Cecil, Vice-President (Compendial Sciences), US Pharmacopoeia. Speaking at a technical seminar on ‘Quality by Design’, organised to mark the 4th annual general body meeting of Pharmaceuticals Export Promotion Council (Pharmexcil) here on Friday, Dr Cecil said the industry nee ds to develop scientific understanding of critical processes and attributes followed by the US Food and Drug Administration (US FDA) in drug approvals. The drug manufacturers should utilise knowledge gained over the product life cycles to operate under norms of quality by design. “There is also a need for evaluating post-approval changes in the products/regulations. Because with an approval the FDA is saying to industry that we trust you and it should kept,” he added.

— Our Bureau

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