GMP for Dietary Supplements - They're Here! June 25, 2007
On Friday, June 22, FDA released the long awaited cGMP for Dietary Supplements.Read FDA's Final Rule and the GMP regulation.Read FDA's Press Release and their Backgrounder document.Read FDA's Consumer article on the Safe Use of Dietary Supplements.Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on cGMP for Dietary Supplements.
GMP Training Systems is announcing the FIRST workshop and web seminar to examine this new regulation.Web seminar July 13 from 11:00 am to Noon EDT. For info and to register, go to:www.gmptrainingsystems.com/asp/gmp_store_070713.aspWorkshop August 1 and 2 in Anaheim/Newport Beach, California. For more information and to register, go to:www.gmptrainingsystems.com/asp/public_workshops.aspGMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1183 clients since 1996NEW! NEW! NEW!Fundamentals of HPLC workshop LIVE on-the-webJuly 13, 20, and 27This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.www.gmptrainingsystems.com/asp/lc_store_070713.aspOur next GMP Boot Camp is July 18 - 19 Virginia Beach,VAwww.gmptrainingsystems.com/asp/public_workshops.aspAlmost full - call now to reserve your seat.Please forward this post to others in your organization who might benefit.
FDA Under Pressure to Inspect Foreign Firms - June 21, 2007
An article in the Washington Post states that generic drugs are increasingly being manufactured by companies based in India and China. Analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pills made in the USA, come from India and China. The article states that experts say medicines from China and India pose a risk of being contaminated, counterfeit or simply understrength and ineffective. William Hubbard, a former FDA associate commissioner, called the situation dire and deteriorating. "You have this confluence of events, with so much more product coming from abroad and fewer and fewer inspections," Hubbard said. "This is very serious stuff, because a contaminated drug hitting the market could cause lots of injuries or worse before it got tracked down." He also said that the FDA inspection system is so weak that many foreign manufacturers believe they "can play games without consequences."Read this entire article. Go to:www.gmptrainingsystems.com/asp/resources.aspClick on Timely Resource Articles and scroll down.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1177 clients since 1996NEW! NEW! NEW!
Fundamentals of HPLC workshop LIVE on-the-web
July 13, 20, and 27
This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.
www.gmptrainingsystems.com/asp/lc_store_070713.aspOur next GMP Boot Camp is July 18 - 19 Virginia Beach,VAwww.gmptrainingsystems.com/asp/public_workshops.aspJust a few seats left in this workshop.Please forward this post to others in your organization who might benefit.
FDA Takes More Heat from Congress - June 12, 2007
This week USA Today had the following headline – FDA called “cozy” with Drugmakers. The story reads that while revising their drug-review policy last year, FDA officials met 112 times with industry representatives but only five times with consumer and patient groups, according to data out Monday from the House Appropriations Committee.
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Rep. Maurice Hinchey, D – N.Y. said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate."
Our Analysis and Speculation
FDA may conduct harsher inspections to prove that they are “less cozy than perceived.” Be prepared for tougher inspections.
GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1167 clients since 1996
NEW! NEW! NEW! Fundamentals of HPLC workshop LIVE on-the-web
July 13, 20, and 27
This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.
www.gmptrainingsystems.com/asp/lc_store_070713.asp
Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VAwww.gmptrainingsystems.com/asp/public_workshops.aspWho in your group needs to come up to speed quickly?Please forward this post to others in your organization who might benefit.
Shades of 1937 and AMO's Response - June 4, 2007
On June 1, FDA issued an Import Alert to prevent toothpaste containing the poisonous chemical diethylene glycol from entering the United States. Diethylene glycol is the same ingredient that led to deaths of over 100 people in 1937 during the infamous elixir of sulfanilamide incident. This tragedy led directly to the passage of the Federal Food, Drug, and Cosmetic Act in 1938.Read FDA's Press Release as well as an FDA article, "Taste of Raspberries, Taste of Death," detailing the 1937 incident. Go to www.gmptrainingsystems.com/asp/resources.aspClick on Timely Resource Articles and scroll down.Here's a quick follow-up to last week's recall by Advanced Medical Optics. The company said it "Stands by its product and blamed improper handling of contact lenses for the eye infections that forced the product to be pulled from the shelves." Do you think it's a smart strategy to blame your customers? Would it not have been a better strategy to say something like, "Together with the Centers for Disease Control and Prevention, we are continuing to investigate the cause of the eye infections that seem to be associated with one of our products. Because we value the health and welfare of our customers, we have voluntarily recalled the product. We will continue to search for the possible causes and immediately rectify any issues should they prove to be associated with our manufacturing or distribution processes."Stay tuned to see how this develops.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1161 clients since 1996 Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VAwww.gmptrainingsystems.com/asp/public_workshops.aspThere are still a few seats left.Please forward this post to others in your organization who might benefit.
