August 2013

For Pharmaceutical Companies

Review of FDA Guidance "Codevelopment of Two or More New Investigational Drugs for Use in Combination"

by: Seth A. Mailhot, Sheppard Mullin Richter & Hampton LLP

On June 14, 2013, FDA issued the Guidance “Codevelopment of Two or More New Investigational Drugs for Use in Combination.” The guidance discusses FDA’s recommendations for developing an entirely new combination therapy where none of the drugs to be used in combination have been previously developed. FDA notes in the guidance that the recommendations do not apply to combination therapies involving previously developed drugs, or the combination of a new drug with a previously developed drug. While codevelopment has generally been centered in oncology and infectious disease, FDA’s guidance is intended to address codevelopment from a high-level, making it applicable to other diseases.

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Elements of Effective Quality Agreements

by: Steven Sharf, GMP Concepts

Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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Avoiding Human Error in Design

by: BW (Ben) Marguglio, BW Marguglio, LLC

Any enterprise that is engaged in activities with the potential for public and employee harm should be encouraged, if not required to develop and implement an integrated risk management, safety management, quality management and environmental management system for the prevention of events with intolerable effects. Such a management system would establish various techniques by which to analyze the safety and quality of the designs of hardware and processes.

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What Does a New FDA Quality Office Mean?

by: Cindy Fazzi, MasterControl Inc.

The news that the FDA is creating a new Office of Pharmaceutical Quality probably set off the alarm bell for the industry. Does a new quality office mean new requirements? It’s the first question that comes to mind.

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Coming Soon:

In the next issue of GxP Lifeline…

Cathy Burgess, partner at Alston and Bird LLC, explains FDA’s newly- released draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.”  Cathy is a frequent Gxp Lifeline author who is adept at explaining FDA’s guidance documents. 

If you’ve ever wondered what the buzz about “the cloud” really means, don’t miss Victor Gill’s article on cloud basics.  He’ll explain the basics of cloud computing so you can really understand the subject. Cloud computing is having a major impact on the pharmaceutical industry.

Who invented quality in manufacturing?  Where did the idea come from and how does it affect pharmaceuticals today?  Tim Donaldson explores the idea in “Using History to Predict the Future of Quality.”

You can find articles by many pharmaceutical experts in GxP Lifeline’s archives
Take a look today!

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