April 2013

For Pharmaceutical Companies

Implementing a Systems Approach to Pharmaceutical Quality Systems

by: Christine Park, Quality Architech, Christine Park & Associates

In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.

In addition, the International Conference for Harmonization (ICH) issued the Q10 Guideline, which describes a model for the implementation of an effective quality management system for the pharmaceutical industry. This guidance integrates key current Good Manufacturing Practice (cGMP) concepts from the pharmaceutical industry with risk management principles, and sets the stage for a systemic approach to pharmaceutical development and manufacturing.

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The European Qualified Person - What's It All About?

by: Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

Differences between the European Union (EU) and U.S. GMPs are generally small and easily manageable.There is one significant exception: the Qualified Person (QP). In many U.S. companies, this concept is unfamiliar. In the U.S., a similar role is fulfilled by the Head of Quality. He or she is legally responsible for all quality decisions, including batch release, but there are differences.

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How Social Media Is Advancing Healthcare

by: Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants Inc.

Because of its 2012 IPO, Facebook has lately received a lot of media attention. While the news has been mostly financial, the huge sums of money being discussed are not the only numbers that can give pause. Facebook boasts a staggering 900,000,000+ users. To put that in perspective, if Facebook were a country, it would be the third largest in the world. And while Facebook is the biggest, it's not the only social networking giant. Depending what source you consult and how you count, there's another dozen or so social media sites with 100,000,000 or more active users. It's hard to believe that, as little as seven years ago, Facebook was still in its infancy, unavailable to the general public, and many of the other popular sites didn't yet exist. Journalist Tom Friedman humorously observed that, "way back then," Twitter was just a sound, the Cloud was something in the sky, applications were something you sent to college, and Skype was a typo.

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