September 2013

For Pharmaceutical Companies

New Draft Guidance on Quality Agreements: No Passing the Buck on CGMPs

by: Cathy L. Burgess, Donald Segal, Guillermo Cuevas

Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements. This article outlines what is new in the draft guidance, including recommendations regarding quality agreements.

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by: Victor Gill, MasterControl Inc.

What exactly is Cloud? Or is it The Cloud? Vic Gill provides an overview of what “cloud” is and what it can do for your business.

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The Cost of Creating A New Drug Now $5 Billion, Pushing Big Pharma to Change

by: Matthew Herper, Forbes Staff

There’s one factor that, as much as anything else, determines how many medicines are invented, what diseases they treat, and, to an extent, what price patients must pay for them: the cost of inventing and developing a new drug, a cost driven by the uncomfortable fact than 95% of the experimental medicines that are studied in humans fail to be both effective and safe. Is this model sustainable in the long run?

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Coming Soon:

In the next issue of GxP Lifeline…

MasterControl’s Walt Murray is back to explain how to implement a master validation plan.  Walt is an experienced consultant with years of practice in this area.

Dr. Robert Kunka writes about “Developing a Winning FDA Strategy for New Pharma Products.” Bob is a clinical drug development consultant with The Kunka Group, Inc. who has helped develop 28 approved pharmaceutical products in eight therapeutic areas.

MasterControl’s Cloud expert Victor Gill is back with a second installment on “MasterControl.Cloud.”  In his first article, he explained in layman’s terms what the Cloud is. In the next issue, he’ll talk about how working in the Cloud can make you more efficient in your work.

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