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How Firms Are Using ICH Q12 Guideline To Reduce US FDA Oversight Of Manufacturing Changes

 
• By Bowman Cox

Sandoz reduced established conditions by 19% in one BLA; others are having similar successes in focusing change control oversight more narrowly. But there have been some pitfalls.

A more modern pharmaceutical establishment
more plant upgrades with less oversight delays • Source: Shutterstock

Most pharmaceutical companies that have incorporated features from the International Conference on Harmonisation’s Q12 lifecycle management guideline into their applications to the US Food and Drug Administration for new drug approval or biologics licensing have won reduced oversight of future manufacturing changes.

For example, Sandoz International GmbH recently used ICH Q12 tools to win reduced oversight of potential changes, regulatory CMC...

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