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Link Between Supply Chain Complexity and Recall Severity Continued in 2009

This article was originally published in The Gold Sheet

Executive Summary

Outsourcing linked to Class I recalls and warning letters.

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Drug Makers Focus on Involving Top Management to Prevent Quality Failure

A Play Book for getting C-level attention to quality could be to wait for the fiasco. But speakers at the recent ISPE Washington conference had some better ideas. They talked about creating an ICH Q10 quality system that brings senior managers into the loop. They explored the importance of establishing a 'quality culture,' which starts with senior management. Don't delegate the quality system design to Quality, they said. And make sure there is a strong and responsive management review system in place. They also went over some of the common objections to investing in quality - and their favorite rebuttals. They explored the use of 'product quality stewards' and described a difficult investigation into mysterious glass breakages.

Drug Makers Focus on Involving Top Management to Prevent Quality Failure

A Play Book for getting C-level attention to quality could be to wait for the fiasco. But speakers at the recent ISPE Washington conference had some better ideas. They talked about creating an ICH Q10 quality system that brings senior managers into the loop. They explored the importance of establishing a 'quality culture,' which starts with senior management. Don't delegate the quality system design to Quality, they said. And make sure there is a strong and responsive management review system in place. They also went over some of the common objections to investing in quality - and their favorite rebuttals. They explored the use of 'product quality stewards' and described a difficult investigation into mysterious glass breakages.

FDA and EMA Revising GMP Regulations to Address Supply Chain Deficiencies

FDA, EMA revising GMPs to establish supply chain controls. FDA looks to require identification and auditing of ingredient suppliers, heightened component security, notification of significant defects. EMA to require detailed API supply chain pedigrees and more technical agreements. QPs will have to really vouch for API sites. FDA also plans other GMP changes.

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