One of our magazine’s regular and most popular contributors is John Avellanet, managing director and principal of Cerulean Associates. (His most recent article, from our June issue, focuses on data integrity and understanding FDA’s current thinking on 21 CFR Part 11.)

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By Ali Afnan, Ph.D., Principal, Step Change Pharma, Inc.

The drug industry today is suffering from a lack of innovation. If it continues along this path, only stagnation can result.

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Last year brought news of important research on the state of the Quality by Design movement in the pharmaceutical industry. This previously unpublished report, Understanding Challenges to Quality by Design, was commissioned by one of the world’s leading regulatory agencies, and completed by one of the world’s best known management consultants.

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In the cover story of Pharmaceutical Manufacturing’s May issue, Gawayne Mahboubian-Jones, PAT expert and Program Manager for Excellence in Science and Design for Philip Morris, asks the question: Can You See the Real QbD? In other words, is the brand of QbD that the industry is now implementing (or, in many cases, contemplating) the kind that was originally intended within FDA, and the kind that is faithful to the Quality by Design principles of Joseph Juran.

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This week in Bethesda, the Generic Pharmaceutical Association (GPhA) and FDA are hosting a workshop on the application of Quality by Design to ANDAs, the purpose being to provide more insight as to how QbD can be leveraged within the generics sector. (The event is sold out, which is a good sign.) In conjunction with the meeting, GPhA has posted two comprehensive draft case studies:

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By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

It was around 2002. The message of change was in the breeze. At FDA’s advisory committee meetings, the language of science was used to examine and discuss Good Manufacturing Practices (GMPs), both in practice and in law. To support and enhance the milieu for change, and to prevent GMP’s from getting in the way of innovation, the “GMP’s for the 21st Century” program was initiated.

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