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News In Brief from “The Gold Sheet” on LinkedIn

This article was originally published in The Gold Sheet

Executive Summary

Ben Venue shuttered; Teva squeezed; Wockhardt troubled; McKinsey would cut inventories and shortages; FDA says why it won’t review some ANDAs – what are they saying about it at “The Gold Sheet” on LinkedIn? Join the discussions of these and other recent news developments at “The Gold Sheet” LinkedIn group.

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EU GMP Updates in Brief

Why EU GMP certificate suspensions hit two Chinese API firms and an Austrian drug maker, and why Wockhart site’s suspension was expanded to include critical APIs.

Regulators Encourage Transition from Batch to Continuous Processing

As pharmaceutical manufacturers increasingly look to continuous processing technologies as a way of controlling costs and potentially increasing drug quality, regulators in the U.S. and the European Union are beginning to use more flexible, quality-by-design-like approaches in evaluating these systems.

Attention Turns to the Business Case for Quality by Design

The business case for quality by design is drawing scrutiny as the cost of QbD-related process design experiments mounts and regulatory incentives languish. FDA officials encourage industry to concentrate on the business benefits of QbD. CMC pilots raised questions about cost effectiveness. McKinsey consultant argues that the QbD business case is strong but little understood. One key is to utilize resources more, as other industries do. Another is to reduce the cost of drugs by speeding up process development like IBM and auto makers did. If it's quick enough, it can wait until after clinical proof of concept. QbD offers $20 billion to $30 billion of additional profits, mainly by reducing the cost of goods sold, particularly through cycle time reduction, and also by improving the productivity of technology development. But perhaps the most important advance would involve basic research such as NIPTE is planning to do that would establish first principles of pharmaceutical engineering, obviating the need for costly and time-consuming empirical design studies.

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