GMP Tips - Laws Enforced by FDA - May 27, 2008

FDA has compiled a list of all the laws and related statutes that they enforce. To see this list, go to:

www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1424 clients since 1996

Upcoming workshops
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Drug Company Shut Down by FDA - May 19, 2008

FDA announced last week that Scientific Laboratories Inc. signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

"The FDA will take action against companies and their executives who violate the law and endanger public health," said Margaret O'K. Glavin, associate commissioner for Regulatory Affairs. "The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs."

Read FDA's Press Release. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Tip
Use information like this in your GMP trainings to reinforce the need to follow cGMP and related laws and regulations.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1417 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Customer Complaint Handling - May 12, 2008

FDA recently issued a Warning Letter to National Biological Corporation citing deficiencies in handling customer complaints and following their own caPA (Corrective and Preventive Action) procedures. This particular Warning Letter gives us insights into what FDA expects in managing customer complaints for medical devices.

Read this Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1411 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Training - Merck gets Warning Letter - May 5, 2008

Merck and Company, Inc. received a nine-page Warning Letter from FDA on April 28. In addition to citations for some of their drug products, they were also cited for cGMP deficiencies concerning bulk drug substances and drug components. Areas cited included Production and Process Controls, Failure Investigations, Laboratory Controls, Buildings and Facilities, Maintenance of Equipment, and Containers and Closures. This letter also contains FDA's reaction to Merck's responses to a previous FDA-483, Inspectional Observations, issued previously.

GMP Tip
Warning Letters give us insight into how the FDA thinks and what they are looking for. Use this and other Warning Letters in your GMP training sessions to reinforce the requirement to always follow cGMP and as an example of what could and does occur when FDA finds your company out of compliance.

Read this Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1407 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.