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April - June 2012

Holly Scott

What to Expect When They're Inspecting - Part II

by Holly Scott
Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

The first segment of this series focused on some of the non-traditional variables that can have an effect on any FDA inspection and how to achieve a positive outcome regardless of the inspectional conclusion. That article generated some blog discussion on FDA's objectivity. I wanted to clarify some of those issues. FDA Investigators are trained to be objective in all situations and will approach their inspection in this manner. However, firm management needs to understand that when intentional barriers to an effective inspection are presented or the FDA Investigator is met with a less-than-cooperative attitude, the realistic conclusion is that management is trying to hide objectionable GMP conditions, leaving the Investigator no choice but to be even more thorough to ensure there are no safety or quality risks to the consumer. It isn't that an FDA Investigator is showing bias or being subjective, they're "Investigators" - it's their job to do so.

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Martin Browning

Annex 11: The EU's New Expectations for Regulated Computerized Systems

by Martin Browning
President and Co-Founder, EduQuest

In 2011, the European Union (EU) revised its guidance for the life cycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. The guidance, called Annex 11, also was revised in response to an alarming number of problems detected in computerized systems.

Annex 11 is one of several guidance documents that supplement the EU's GMP rules (EUDRALEX Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice). It applies to all human and veterinary medicinal products made or sold in the EU.

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Christine Park

Surviving the Back Room During an FDA Inspection

by Christine Park
Christine Park & Associates

During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

The investigator requested a specific document which was brought into the room. During the review, the investigator asked to speak to the individual who had signed the document. Unfortunately, there was no one in the room who could identify the signature. Things started to deteriorate quickly from that point on. It was obvious that while team members were able to locate the document, there were issues within the document, creating more questions and concerns from the investigator. I found myself stepping out of the inspection to set up a mini backroom process to screen the documents prior to sending them to the investigator. Granted, if there were errors in documents, there was no time to fix them, but at least we were able to explain and address them.

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Cindy Fazzi

How Life Science Companies Can Leverage Mobile Technology

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one.

More and more employees use them not just for personal reasons, but to perform some of their work. In many cases, companies are forced to provide IT support for these employees. Those companies find themselves having to catch up with their employees who are leveraging mobile technology.

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Did You Know?

ASQ - World Conference on Quality and Improvement
May 21-23, 2012, Anaheim, CA

CAP 2012 - The Pathologists' Meeting™
September 9-12, 2012, Manchester Grand Hyatt, San Diego, CA

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Did you know that deviations related to FDA's Part 11 are still an issue? "A recent example is a warning letter from February 2012. Cited deviations have been related to security, integrity and availability of electronic records."
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