Another contact lens solution recall - Nov 30, 2006

Last week Advanced Medical Optics announced a voluntary recall of 18 Lots of Complete(R) MoisturePLUS(TM) Contact Lens Care Products distributed and sold in the United States.

The company launched the recall after testing of products determined that three production lots were found to be non-sterile and contaminated with bacteria.

Read the entire recall notice. Go to
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

Earlier this year Bausch and Lomb had their own problems with contaminated batches of eye solutions. You can find the FDA483 and Warning Letter issued to Bausch and Lomb on the same Resources page.

Training Tip
Use these examples in your GMP training sessions and company meetings to discuss how you can prevent situations like these from occurring in your company.

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ICH Q10 - Quality Systems - Nov 27, 2006

Joseph Famulare, FDA's Acting Deputy Director at the Office of Compliance of CDER, recently gave a presentation on the newly proposed ICH guideline on Quality Systems, known as Q10.

This guideline will describe a model for an effective Quality System needed to establish and maintain a state of control that can ensure the realization of a quality drug product and facilitate continual improvement over the product life cycle.

ICH is the International Conference on Harmonization
CDER is the FDA Center for Drug Evaluation and Research

You can download the presentation at
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 987 clients since 1996

Our Instructor-led GMP Training System is available in both English and Spanish versions. In 2007, pricing is going up. Download a sample module to preview this innovative product. Go to
www.gmptrainingsystems.com/asp/gmp_training_system.asp

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FDA Commissioner Nomination Put on Hold - AGAIN! - Nov 17, 2006

WASHINGTON -(Dow Jones)- Senate Finance Chairman Chuck Grassley, R-Iowa, has placed a hold on the nomination of Andrew von Eschenbach as the Food and Drug Administration commissioner.

In a letter sent to majority leader William Frist Thursday, Grassley said he is "extremely disturbed by the acting commissioner's continued failure to comply with the committee's subpoenas over the past six months."

In addition, he said, "numerous other committee requests are overdue...from both the FDA and the Department of Health and Human Services."

Von Eschenbach has been acting FDA chief since September 2005.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 976 clients since 1996

David Markovitz, President of GMP Training Systems, Inc. is conducting an audio seminar on Tuesday, Nov 21 on Implementing FDA's New Guidance on Quality Systems Approach to Pharmaceutical CGMP Regulations. For info and to register, go to http://snipurl.com/FDAGuidance

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Election Results & Impact on FDA - Nov 13, 2006

On the very next day AFTER the election, FDA announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.
(Do you think the timing is coincidence?)

A Democratic-led Congress appears willing to make FDA improvements, starting by shuffling a few key committee chairmen.

Democrats Edward M. Kennedy of Massachusetts , Henry A. Waxman of California , and Bart Stupak and John D. Dingell both of Michigan are poised to head key congressional panels with investigatory powers and FDA oversight.

"With congressional oversight, [the FDA is] going to face a much tougher, much tougher environment," said John Manthei , a partner in the Washington, D.C., office of Latham and Watkins LLP . "Mr. Waxman and Mr. Dingell and Mr. Stupak have made it very clear that FDA is squarely within their crosshairs," said Manthei, FDA counsel for the Medical Device Manufacturers Association.

What does this mean for us?
Probably a tougher FDA. Stay tuned.

Read FDA’s Press Release outlining their new action plan as well as a news story published in the Boston Globe with some analysis of the impact this will have on industry.

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

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Today is the final day to register for our last GMP Boot Camp in 2006 - Nov 15 - 16 in Irvine, CA. Only five seats left.
For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.asp

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GMP Tips - Acetominophen recalled - Metal Fragments - Nov 9, 2006

Perrigo Co. recalled 11 million bottles of acetominophen after discovering some were contaminated with metal fragments. The fragments ranged in size from "microdots" to portions of wire one-third of an inch long.

The FDA said Perrigo began investigating after realizing the equipment it uses to make pills was wearing down prematurely.

Read more details in a news story. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

Training Tip
Use this incident in your GMP Training sessions. This is one of the subtleties of GMP. Equipment wear and tear is a natural condition and is best monitored by those closest to the process. A preventive maintenance program should be in place to identify potential problems BEFORE they occur. (One can only imagine how much this recall will cost Perrigo in dollars, delays, reputation, stress, morale, ...)

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 965 clients since 1996

Our last GMP Boot Camp in 2006 is scheduled
for November 15 - 16 in Irvine, CA. Only six seats left.
For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.asp

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GMP Tips - Bausch & Lomb Warning Letter - Nov 6, 2006

Earlier this year Bausch and Lomb received an eleven page 483 from FDA and recalled one of their products.

NOW - they get an eleven page Warning Letter from FDA stating that FDA's "inspection identified and documented significant Quality System regulation violations that were systemic and are relevant to all products manufactured at the Greenville, SC facility."

Read both the 483 and Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resources Articles

Read our April 18 and May 22 postings in our web portal archives to learn more about B&L's journey with FDA.

Training Tip
Use these documents in your GMP training sessions to learn from other people's experiences with FDA. (Do you suppose the stress level is pretty high at B&L these days?)

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 957 clients since 1996

Our last GMP Boot Camp in 2006 is scheduled
for November 15 - 16 in Irvine, CA. Only six seats left.
For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.asp

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GMP Tips - A Picture = 1000 Words - Nov 1, 2006

It's true - a picture is worth one thousand words. Most people are visual learners, they learn with their eyes. So when conducting training it is always very useful to use pictures, charts, graphs, and other visuals.

We recently found the cover of FDA's Newsletter from November 1962. It has a photo of President John F. Kennedy signing the Kefauver-Harris Drug Amendments to the Federal Food Drug and Cosmetic Act. We are incorporating this picture into our training sessions, and recommend that you do as well. There is also a photo of President Kennedy presenting Frances Kelsey, an FDA researcher, with an award in 1962 for her role in preventing the approval of Thalidomide.

Download this document at:
Go to www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 951 clients since 1996

Our last GMP Boot Camp in 2006 is scheduled
for November 15 - 16 in Irvine, CA. Only six seats left.
For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.asp

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