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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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 lifecycle 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.

In plain English, Annex 11 wants to ensure the computerized systems you use to manufacture medicinal products have no adverse impact on product quality, product efficacy, or patient safety. In addition, when a computerized system replaces a manual operation, Annex 11 wants to ensure there are no increased risks.

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MasterControl, Inc. will present "Change Control--a Risk-Based Approach" as a workshop at the MD&M Texas 2012 Conference, March 15, 2012 at the Fort Worth Convention Center in Fort Worth, Texas. MasterControl's Kevin Marcus, product manager and medical device expert, and Walt Murray, director of quality and compliance services, will conduct the workshop.

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