Keep Your GMP Training Fresh!

One challenge we face with GMP Training is keeping it current and fresh. The FDA often is a terrific resource for finding training resource materials. Several FDA personnel conducted presentations at the 41st Annual Meeting of the Drug Information Association on June 26 – 30, 2005. Many of these presentations are posted on FDA’s web site.

One presentation we found particularly interesting was by Richard Friedman from the Center for Drug Evaluation and Research, Office of Compliance, Division of Manufacturing and Product Quality.

Mr. Friedman spoke on Continuous Improvement under Modern Quality Systems and cGMPs. You can download a copy of this presentation at http://www.gmptrainingsystems.com/asp/articles.asp

Many companies are embarking on Continuous Improvement journeys. GMP Training Systems got its start in this area in the early 1980’s. In fact, David Markovitz, Founder and President of GMP Training Systems, was privileged to assist Dr. W. Edwards Deming at several of his famous Four-Day Seminars from 1987 through 1993, when Deming passed away at the age of 93. Deming has been recognized as one of the 20th century’s top one hundred influential persons.

You can learn about some of the in-plant courses we offer in the area of Optimization and Continuous Improvement at http://www.gmptrainingsystems.com/asp/systems.asp

www.GMPTrainingSystems.com

We design and conduct GMP and related training for the Pharmaceutical, Medical Device, and related industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.

Jury Awards Widow $253.4M in Vioxx Trial

This is the first case to reach a decision. There are 4,200 more court cases facing Merck. Analysts have speculated Merck's liability could reach $18 billion. Merck pulled Vioxx, a $2.5 billion seller, from the market in September 2004 when a long-term study showed it could double risk of heart attack or stroke if taken for 18 months or longer.

Although this case is not directly a GMP issue, it points out the impact trouble can have on a company.

Training Tip

During your GMP training sessions, have small groups of people discuss the impact news like this can have on a company. Answers will include things like:

• Stock price drops (causing stockholders to get cranky and put pressure on management to improve performance).
• Reputation of the company is affected, possibly resulting in decreased sales.
• The actual cost associated with the withdrawal of Vioxx.
• Lost revenue – Vioxx was a $2.5 billion seller for Merck.
• The costs associated with legal defense. (Most manufacturing people will quickly point out that lawyers tend to earn more than production operators.)
• Budget tightening at the company.
• More FDA scrutiny.
• Questioning of company officials by Congress.
• Morale could decrease within the company.

These same consequences that Merck is facing could come about by inattention to GMP. The shortage of flu vaccine last fall was a result of contaminated batches. This was certainly a GMP issue.

Click on http://www.gmptrainingsystems.com/ and go to Articles. You can download a News Article about Vioxx and Merck you can use in your training.

www.GMPTrainingSystems.com

We design and conduct GMP and related Training Programs for the Pharmaceutical and Medical Device industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.

Teleseminar on August 16

David Markovitz will be conducting a one-hour teleseminar entitled "Developing and Deploying a Successful GMP Training System." He only does this once a year, and this year it's on August 16 at 11:00 EDT. All you need is a telephone to participate.

Make your GMP training come alive! It doesn’t have to be dull and boring. Discover the Top 28 “Do’s” - Your ingredients for a winning training session and the Top 17 “Don’ts” - Ignore them at your peril! Learn how to make a potentially dry topic such as GMP interesting and, yes, even fun!

To learn more about this unique learning event and how you can register simply click here http://ivthome.com/teleseminar/telebr_44.htm

David Markovitz is the President and Founder of GMP Training Systems. David is the creator of the GMP Ready-to-Use Training System, a product used extensively throughout the FDA regulated industries.

Learn more about this and other useful products at www.GMPTrainingSystems.com

Pharmakon Labs Shut Down

Well, it didn't take long for FDA's new Commissioner to take action. Just days after being confirmed by the Senate, Lester Crawford speaks out. "This action by Judge Lazzara sends a strong signal that FDA will take action against drugs that fail to meet quality standards," stated FDA Commissioner Lester M. Crawford. "As the nation's top enforcer of manufacturing standards, the FDA will continue to ensure that drugs being sold in this country meet those crucial requirements."

On July 26, FDA obtained a permanent injunction against Pharmakon Laboratories, forcing the company to shut down operations. The company manufactures and distributes cough and cold liquids, tablets, and caplets.

Following inspections by FDA and a trial in US District Court, Judge Richard A. Lazzara found that drug products sold by Pharmakon did not meet current good manufacturing practice standards and other legal requirements.

This isn't the first time Pharmakon's manufacturing practices have been questioned. In September 2001, the company received a warning letter citing failure to label proper dosage; failure to establish qualification for manufacturing equipment ancillary systems; failure to validate or establish written procedures for the validation of equipment operations, water quality, or computer software used to calculate batch formulations, and failure to periodically monitor the quality of water used for manufacturing and cleaning.

The defendants were ordered by the Court to halt manufacturing and distributing drugs until they meet FDA’s CGMP standards and receive marketing approvals.

Training Tip

The above example provides a terrific lesson you can use in your GMP training process.

Print a copy of FDA's Press Release and distribute it to your GMP training participants. (You can download a copy here - http://www.gmptrainingsystems.com/asp/articles.asp )

Ask people to examine the reasons stated for the court action. Failure to validate, Failure to establish written procedures, Failure to monitor the quality of water, a key raw material. These are all basic GMP issues and can be addressed.

Ask participants to estimate the cost of implementing fixes for the above. Then ask them to estimate the cost of the shut down. Which do you suppose is cheaper?

Now that this company has been ordered to shut down operations, what becomes of their customers? They will all have to find other suppliers. If and when this company implements fixes and gets FDA's approval to start back up, do you think their customers will stampede back to their doorstep?

This example clearly demonstrates the power FDA has and the willingness of the new Commissioner to use it.

www.GMPTrainingSystems.com

We design and conduct GMP Training Programs for the Pharmaceutical and Medical Device industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.