GMP Tips - Small Business Guide to FDA - July 26

Did you know that FDA has a Small Business Guide?

This concise booklet contains useful information about FDA's organization, procedures, policies, and regulations.

Download a copy at www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources.

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Serving 812 clients since 1996

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GMP Tips - Sanofi Pasteur Warning Letter -July 10, 2006

FDA issued a Warning Letter to one of Sanofi Pasteur's facilities on June 30, 2006. A few days later, on July 3, FDA released a Question and Answer document about this particular Warning Letter.

Q&A documents like this one often provide key insights into FDA and how they think. They discuss why they took the action they did.

Read this important FDA document as well as the Warning Letter, and the FDA 483 issued to Sabofi Pasteur in April 2006.

Go to www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 798 clients since 1996

Our GMP Boot Camp is next week - July 19-20 in Orlando.
To register, go to www.gmptrainingsystems.com/asp/public_workshops.asp

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GMP Tips - FDA Adrift and Floundering? - July 5

Rep. Henry Waxman, Ranking Minority Member of the Committee on Government Reform in the US House of Representatives, released a report on June 27 entitled “Prescription for Harm: The Decline in FDA Enforcement Activity.”

In a statement released along with the report, Waxman says, “I see an agency adrift and floundering. FDA, once the most respected regulatory agency in the world, has seen its powers wither and its reputation plummet over the last five years. Today, the agency’s historic commitment to public health is in doubt.”

OK, you might say that Waxman, a Democrat, is using this report to bash the current administration. Politics is the game played in Washington. Nevertheless, this report will cause FDA officials to spend time and effort preparing a response. This is another in a continuing series of stings FDA has encountered over the past two years.

After being pummeled in the public eye for two years now, one might imagine the toll this is taking on FDA employees throughout the agency. (Read previous postings about the FDA bashing that’s been going on, as well as the revolving door in the Commissioner’s office.)

How might this report impact FDA inspections in our plants?
Will the inspectors tend to be a little more careful, ask a few more questions, be unwilling to give us the benefit of the doubt in close interpretations?
We think so, and we think that we’re in for tougher inspections.

Be prepared.

This is a good time to consider conducting that internal GMP audit.

This is a good time to schedule that GMP training.

These prevention activities will help you and your organization prepare for that next FDA inspection, and you know it will come.

Read Waxman’s report and his statement.
Go to www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 795 clients since 1996

Last chance to register for our GMP Boot Camp
July 19-20 in Orlando
To register, go to www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this post to others in your organization who might benefit.