GMP Tips - FDA Halloween Safety Tips - Oct 30, 2006
FDA has a section on their web site dedicated to Halloween Safety Tips. Find it at http://www.fda.gov/oc/opacom/kids/candyandtreats.html
Happy Halloween from your friends at GMP Training Systems, Inc.
GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 947 clients since 1996Our last GMP Boot Camp in 2006 is scheduledfor November 15 - 16 in Irvine, CA. Only six seats left.For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
GMP Tips - Rear Admirals in the FDA? - Oct 23, 2006
Andrew C. von Eschenbach, M.D., Acting Commissioner of the U.S. Food and Drug Administration today congratulated three senior agency scientists and physicians on their promotions as members of the Commissioned Corps of the United States Public Health Service (USPHS). Rear Admiral Linda Tollefson, D.V.M., M.P.H., was promoted to Rear Admiral, Upper Half (0-8, two-star), and Captains Paul J. Seligman, M.D., M.P.H. and Sandra L. Kweder, M.D., were each promoted to Rear Admiral, Lower Half (0-7, one-star).
One of the seven uniformed services of the United States, the Commissioned Corps of the U.S. Public Health Service is a specialized career system designed to attract, develop, and retain health professionals who may be assigned to Federal, State or local agencies or international organizations. Their mission is protecting, promoting, and advancing the health and safety of the Nation. The FDA is part of the U.S. Public Health Service.
As if the FDA inspectors aren’t intimidating enough, some wear their uniforms which adds to the intimidation factor.
GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 944 clients since 1996Our next GMP Boot Camp is scheduledfor November 15 - 16 in Irvine, CA. Only six seats left.For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
GMP Tips - Crawford Pleads Guilty - Oct 18, 2006
Former FDA Commissioner Lester Crawford pleaded guilty on Tuesday to two charges stemming from his ownership of stock in companies the agency regulated.
Crawford, who resigned from the FDA last year, admitted to making false statements on financial disclosure forms and violating conflict-of-interest laws. His sentencing was set for January 22.
Breaking into tears while talking to reporters, Crawford said he valued his years at the FDA and looked forward to returning to work in the private sector.
“I accept full responsibility for errors and omissions that occurred on my financial reports. This was my fault, no one else's," Crawford told reporters after his court appearance. "Nothing I have done, I hope, can be construed to affect the integrity of the Food and Drug Administration," he said.FDA has had a rough two years, and this news might cause FDA inspectors to play it safe, making for tough inspections in the near future. And this development certainly won't help FDA's case in getting more funding from Congress. GMP Training Systems
www.GMPTrainingSystems.com
Serving 933 clients since 1996Please forward this post to others in your organization who might benefit.
GMP Tips - Former FDA Chief Charged with Lying - Oct 17, 2006
Former FDA Commissioner Lester Crawford was charged Monday with lying about his ownership of stock in companies regulated by his agency. According to the Wall Street Journal, Crawford plans to plead guilty to two misdemeanors in connection with not disclosing investments in companies that his agency regulated.The Justice Department accused Crawford with falsely reporting that he had sold stock in companies when he continued holding onto shares in the firms governed by FDA rules. Crawford also failed to disclose his income from exercising stock options in Embrex, an agriculture biotechnology company regulated by FDA.AND WE'RE STILL WAITING for the Senate to vote to confirm the current Acting Commissioner, Andrew von Eschenbach. He's been Acting Commissioner since September 2005, when Crawford resigned after just two months as Commissioner. Now we know why he resigned. GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 933 clients since 1996Please forward this post to others in your organization who might benefit.
GMP Tips - New OOS Guidance - Oct 16, 2006
In an effort to help pharmaceutical manufacturers evaluate test results, the FDA issued a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer. The designation also covers in-process laboratory tests.The guidance document covers such topics as:- How to investigate OOS test results;
- The laboratory phase of the investigations;
- Responsibilities of laboratory personnel, such as the analyst and supervisor;
- When to expand the investigation outside the laboratory to include the production process and raw materials;
- Additional testing that may be necessary;
- The final evaluation of all test results.
Download a copy of this new guidance "Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"Go to www.gmptrainingsystems.com/asp/resources.aspClick on FDA ResourcesGMP Training Systems, Inc.www.GMPTrainingSystems.comServing 933 clients since 1996
Our next GMP Boot Camp is scheduledfor November 15 - 16 in Irvine, CA. Only seven seats left.For registration information, go to http://gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
GMP Tips - GSK recalls Paxil - Missing Active Ingredient - Oct 12, 2006
GlaxoSmithKline Plc recalled Paxil CR antidepressants last month because the pills may have lacked an active ingredient, and didn't warn patients. Glaxo doesn't know how many of the 7.5-million recalled pills were missing paroxetine hydrochloride, or how many patients took the pills, spokesman Michael Fleming said in a telephone interview.Read the article detailing this at www.gmptrainingsystems.com/asp/resources.aspClick on Timely Resource Articles
Training TipUse this article in your GMP Training. Have small groups discuss how this might have occurred. Then discuss what measures that your company has in place (or needs to put in place) to prevent this from occurring.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 948 clients since 1996David Markovitz, Founder and President of GMP Training Systems, Inc., will be conducting an audio seminar on Implementing FDA's New Guidance on a Quality Systems Approach on Thursday, October 19. For registration information, go to http://gmptrainingsystems.com/asp/bp_store_061019.aspPlease forward this post to others in your organization who might benefit.
GMP Tips - New Guidance Quality Systems Approach - Oct 2, 2006
We knew it was coming, we just didn’t know when. Now it’s here, released by FDA on September 29. Here are some excerpts from FDA’s Press Release.
FDA issued a final guidance on quality systems, a set of formalized practices and procedures to ensure quality of human and veterinary drugs and human biological drug products during manufacturing.
“This guidance incorporates modern quality principles into FDA’s approach to manufacturing, encouraging industry adoption of new technological advances and integrated quality systems,” said Dr. Janet Woodcock, FDA Deputy Commissioner for Operations.
The document demonstrates to industry the benefits of incorporating modern quality principles which should foster technical advancements into their manufacturing processes to better ensure the safety and efficacy of drugs for people and animals.
The aim also is to help produce drugs more efficiently, which should help lower costs and prevent shortages of critical medicines due to manufacturing failures that can result in production stoppages and recalls.
This new Guidance, “Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations” is intended to provide manufacturers of pharmaceuticals with the ability to make technological improvements more readily, with appropriate regulatory oversight. FDA will continue to monitor manufacturing plants through its inspection program and will continue to advance the training of its investigators in the latest technologies.
Get your copy of this new Guidance Document. Go to: http://www.gmptrainingsystems.com/asp/resources.aspClick on FDA ResourcesGMP Training Systems, Inc.www.GMPTrainingSystems.comServing 937 clients since 1996
David Markovitz, Founder and President of GMP Training Systems, Inc., will be conducting an audio seminar on Implementing FDA's New Guidance on a Quality Systems Approach on Thursday, October 19. For registration information, go to http://gmptrainingsystems.com/asp/bp_store_061019.aspPlease forward this post to others in your organization who might benefit.
