Monday, July 30, 2007

FDA says GMP Compliance Going from Bad to Worse - July 30, 2007

At a recent industry meeting, David Horowitz, FDA Office of Regulatory Affairs deputy associate commissioner for compliance policy, noted industry compliance with GMPs "is bad and getting worse." He remarked that manufacturers are "studying for the test"—correcting specific deficiencies but not investing in systems that can avoid problems and correct root causes.

FDA is urging manufacturers to adopt innovative approaches for ensuring that drugs meet quality standards, as seen in its Quality Systems Approach to Pharmaceutical CGMP Regulations guidance published in September 2006.

The new Q10 standard from the International Conference on Harmonization further describes approaches for harmonizing quality systems on a global basis.

How is GMP compliance in your company?
Bad and getting worse?
OR
Good and getting better?

Find both FDA’s guidance and the Q10 document at:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1223 clients since 1996

Upcoming web seminars
Aug 2 Commissioning and Validation of Critical Utilities series
Aug 10 How to Manage Regulatory Inspections series
Aug 23 Sample Preparation for HPLC
Aug 30 Common Problems with Gradient Elution Liquid Chromatography: Proven Solutions and Prevention Strategies
Sept 20 The Effective Use of Statistics in Design Method Validation series

See our entire Web Seminar schedule:
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach,CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Monday, July 23, 2007

Contamination! AIDS Drug Recalled - July 23, 2007

Roche Pharmaceuticals last month announced a global recall of its HIV/AIDS drug Viracept after discovering that some batches had been contaminated with a carcinogen during a flawed manufacturing process at its Swiss plant.

Tens of thousands of people take Viracept worldwide, most of them poor people with the acquired immune deficiency syndrome in developing countries.

A spokeswoman for Roche said the contaminant, ethyl mesilate, should be called an "impurity" rather than a contaminant because it was created in the manufacturing process and because this type of chemical can be found in very low levels in other medicines, although it was not supposed to be present in Viracept.

At high doses, ethyl mesilate has been shown to cause cancer in animals, and at lower levels it has caused genetic mutations, but data are extremely limited.

It is particularly harmful to children and pregnant women.

Impurity or contaminant – it’s a GMP problem!

Training Tip
In your GMP training sessions, discuss the impact of issues like this on poor people in developing countries. They have enough challenges in life, and this just compounds their struggle to exist.

Read the entire article published in the New York Times on July 23. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.


GMP Training Systems, Inc.

www.GMPTrainingSystems.com
Serving 1217 clients since 1996

Upcoming web seminars
July 27 Sample Preparation for HPLC
Aug 2 Commissioning and Validation of Critical Utilities series
Aug 10 How to Manage Regulatory Inspections series
Sept 20 The Effective Use of Statistics in Design Method Validation series

See our entire web seminar schedule:
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach,CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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

Thursday, July 19, 2007

ICH Q10 Ready for Comment - July 19, 2007

The FDA recently announced the International Conference on Harmonization (ICH) draft guidance Q10 Pharmaceutical Quality System in the Federal Register. The public comment period is open until October 11, 2007.

The ICH Q10 draft guideline describes one approach for “an effective pharmaceutical quality system that is based on ISO concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH Q8 ‘Pharmaceutical Development’ and Q9 ‘Quality Risk Mangement.’” The guideline, which is optional, applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.

Read the Q10 Guidance document. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.

www.GMPTrainingSystems.com
Serving 1214 clients since 1996

See our web seminar schedule
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27

Anaheim/Newport Beach,CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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

Thursday, July 12, 2007

Chinese FDA Chief Executed!!! July 12, 2007

BEIJING, July 10 (Bernama) -- The Supreme People's Court executed former director of China's State Food and Drug Administration (SFDA) Zheng Xiaoyu on Tuesday morning, after finding him guilty of taking bribes amounting to US$850,000 (6.49 million yuan) and dereliction of duty.

Read a full article detailing this startling action. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Correction: Cao Wenzhuang, who we reported on earlier this week, was former head of the drug registration department of the SFDA, not Chief.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1199 customers since 1996

Monday, July 09, 2007

Chinese FDA Chief gets Death Penalty - July 9

BEIJING, July 7 (UPI) -- A former top official with the state Food and Drug Administration in China has been sentenced to death for taking bribes to approve defective drugs.

Cao Wenzhuang was given a two-year reprieve Friday on the execution of his sentence, The New York Times reported. That means there is a good chance the sentence will be commuted to life imprisonment, the newspaper said.

In February 2007, former FDA Commissioner Lester Crawford was sentenced to three years' supervised probation with fines of roughly $90,000 for lying about stocks he owned in companies regulated by the FDA while he was Commissioner. Crawford pled guilty in October 06 to charges of having a conflict of interest and false reporting of his stock records.

Crawford should be thankful he headed the US FDA and not China’s FDA.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1197 clients since 1996

Last call for our GMP Boot Camp July 18 - 19
Virginia Beach,VA

www.gmptrainingsystems.com/asp/public_workshops.asp
Only three seats left!

Understanding cGMPs for Dietary Supplements
Web seminar July 13
For more information and to register, go to: www.gmptrainingsystems.com/asp/gmp_store_070713.asp

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

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

Monday, July 02, 2007

Medical Device Consent Decree - July 2, 2007

Shelhigh, Inc., of Union, N.J., agreed to stop distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with FDA standards.

Shelhigh manufactures pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts.

Pediatric heart valves. Every parents' nightmare is to be told that your baby needs heart surgery and possibly an artificial valve to replace the defective valve they were born with. What would you do if your baby had a valve replacement three months ago and today you discover it was a Shelhigh valve?

On April 17, 2007, U.S. Marshals seized all finished devices and components of the devices at Shelhigh's manufacturing facility due to concerns of potential risk of nonsterility.

The consent order requires that the company hire independent expert consultants to inspect its facility and certify to FDA that corrections have been made. (How much do you think this will cost vs. the cost to prevent this from occuring in the first place?)

Read FDA's Press Release announcing this Consent Decree.

Go to: www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip
During your GMP training sessions, discuss how nonsterile products could occur in your facility. Discuss the importance of following procedures. Discuss the consequences and cost that Shelhigh now faces and the potential impact on its employees.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1189 clients since 1996

Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp
Only three seats left!

NEW! NEW! NEW!
GMP for Dietary Supplements Boot Camp
August 1 and 2 Anaheim/Newport Beach, California.
For more information and to register, go to:
www.gmptrainingsystems.com/asp/public_workshops.asp

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

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