Pharmaceutical Manufacturing, the only publication devoted exclusively to drug manufacturing and scaleup, is dedicated to sharing best practices that will help drug industry professionals.

• Improve product quality while ensuring regulatory compliance
• Reduce cycle times, inventories and plant downtime and eliminate waste
• Empower manufacturing and operations staff
• Eliminate organizational and information silos
• Reduce time to market for new drugs—drugs that can actually be manufactured

Unlike broader publications that cover the entire pharmaceutical life cycle, Pharmaceutical Manufacturing's print and digital products focus on the manufacturing, quality and scaleup functions so critical to the industry's future.

Pharmaceutical Manufacturing's editors search for examples of best practices from all over the world, so that readers can learn from their peers and the experts who are actively applying the principles of quality by design and scientific manufacturing, each and every day, at their facilities.

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Geographic Eligibility: International

Publisher: Putman Media

Read the Digital Issue: Pharmaceutical Manufacturing, May 2009

Cover Feature
Compliance: Are You Truly in Control?
Compliance shouldn't be a roll of the dice, but for many companies it is. What else would explain the steady stream of 483s and more consequential reprimands flowing forth from FDA?

More and more, it's process control that is the top compliance conundrum. Regulatory expert Michael Gregor spotlights current trends in compliance, including what FDA's won data reveals.

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OVERVIEW

In Pharma, manufacturing has never been more important. And Pharmaceutical Manufacturing is leading the way.

At most drug companies today, attention and resources are focused, as never before, on scale up and manufacturing operations. The reasons for this focus are clear:

• Noncompliance with FDA regulations continues to challenge drug companies, which continue to receive 483s and warning letters from FDA citing cGMP and quality deficiencies
• The pace of new drug introductions has slowed, and many new drug candidates ultimately prove to be "unmanufacturable," wasting hundreds of millions of R&D dollars each year
• As global competition intensifies, industry profit margins are thinning, yet public and political pressures are intensifying; more people are demanding that drug manufacturers reduce product prices

At the same time, FDA is transforming its old "command and control" approach to regulation, emphasizing the need for process understanding, risk assessment, and Quality by Design. The Agency has outlined a new vision for drug manufacturing, but has not mapped out how to get there.

As a result, drug manufacturing professionals need actionable, inspiring examples of how their peers and thought leaders within the industry, are applying the principles of Quality by Design and Operational Excellence to drug scaleup, manufacturing and packaging. They also need to see how manufacturing fits into the bigger picture of improved drug development, supply chain management and customer satisfaction.

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