ICH introduced risk based approaches and enhanced scientific understanding as an opportunity to encourage continuous process improvement facilitate the introduction of newer technology. In addition, Quality by Design (QbD) promised to improve confidence in quality through the lifecycle of pharmaceutical products. A primary incentive for industry remains the prospect of global regulatory concordance for new applications and post approval changes, and ICHQ12 holds much promise. However, during the last decade, the industry has experienced a proliferation of regulatory divergence regarding the interpretation of ICH guidelines (and control strategies) across geographic regions, including “anxiety†for adoption and implementing ICHQ12. This presentation will illustrate some examples of divergence in control strategies while exploring opportunities for improved harmonization.
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