Monday, August 18, 2008

GMP Tips - Avoiding Recalls - August 18, 2008

Actavis Totowa LLC just announced a voluntary recall of all drug products manufactured at its Little Falls, New Jersey, facility. This is a voluntary action following an inspection conducted by the US Food and Drug Administration earlier this year. Approximately 55 products are being recalled.

According to a statement from the company, “The inspection at Little Falls revealed operations that did not meet the FDA’s or Actavis’ standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.”

The current recall is the third recall by the company this year. In April, Actavis Totowa initiated voluntary recall of “Digitek” (digoxin tablets, USP, all strengths) for oral use. That recall was due to the possibility that tablets with double the appropriate thickness may have been commercially released and that the tablets may have contained twice the approved level of active ingredient.

In March, Actavis’ subsidiary Actavis South Atlantic LLC recalled fentanyl transdermal system CII patches sold in the United States. The recalled patches were manufactured by Corium International (Menlo Park, CA), a contract manufacturer for Actavis. The fentanyl transdermal system patches recalled may have had a fold-over defect that has the potential to cause the patch to leak fentanyl gel. As a precaution, Actavis recalled the products.

GMP Training Tip

Use this example in your GMP training sessions. If you produce tablets, ask the question, “How could they have produced, tested, approved, and shipped tablets that were DOUBLE the appropriate thickness?" and discuss answers.

Discuss the impact of recalling 55 products. How will this affect the company, the workers, their reputation, their future sales?

GMP Training Systems, Inc.
www.GMPTrainingSystems.com

Serving 1468 clients since 1996

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FDA Survival Kits
Buy one of our Survival Kits and get one hour telephone consultation with the developer/author absolutely FREE. A $500 value!!!!!

Web seminars
Buy three of our archived web seminars, and get the fourth one FREE! You get the MP3 file (or CD) of the audio program and all handout files for each program. A savings of $397.00!!!!!!

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA

Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23
Mexico City, Mexico

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

Monday, August 11, 2008

GMP Tips - New Employee Orientation - Aug 11, 2008

Your best chance to ensure compliance with GMP from your people is to give them their first dose of GMP training during their New Employee Orientation. The basic message at the start is to make sure that everyone knows that they are working in a regulated industry, and following procedures is first and foremost critically important in this environment.

People may be joining your company from places where they are free to make changes (improvements) where and when they see fit - without documentation. The FDA regulated industries are different - changes must flow through a formal Change Control process and must be documented.

GMP Tip
These are two points you want to drive home at the very start of someone's tenure with your company.
  1. Follow procedures, and if for whatever reason you cannot, stop and alert your supervisor.
  2. Any change to a process must be reviewed and approved before it can be implemented.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com

Serving 1465 clients since 1996

Big summer savings! Available during August only

GMP Training System (Instructor-led version)
Buy the English version and get the Spanish version for 50% off. A savings of $2,100.00!!!!!!! Ideal for new employees, temps, contractors, and for annual refresher training.

FDA Survival Kits
Buy one of our Survival Kits and get one hour telephone consultation with the developer/author absolutely FREE. A $500 value!!!!!

Web seminars
Buy three of our archived web seminars, and get the fourth one FREE! You get the MP3 file (or CD) of the audio program and all handout files for each program. A savings of $397.00!!!!!!

Call us at 714-289-1233 to take advantage of these fantastic savings!


Upcoming workshops

Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA

Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23
Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

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

Wednesday, August 06, 2008

GMP Tips - Effective Response to FDA 483 - August 6, 2008

Just last week a Warning Letter was issued to NeoChild LLC. In this Warning Letter FDA takes issue with several of the company's responses to the the FDA 483, List of Inspectional Observations, that they received during an FDA inspection.

This particular Warning Letter provides very specific insights into FDA's current thinking and outlines their expectations on specific issues. We recommend that you share this Warning Letter with those in your company responsible for dealing directly with the FDA during inspections.

GMP Tip
Use this letter and other Warning Letters in your GMP training to discuss specific GMP issues and whether your company may be vulnerable. Learning from other people's experiences with FDA can keep you out of trouble with the FDA.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com

Serving 1463 clients since 1996

Big summer savings! Available in August only

GMP Training System (Instructor-led version)
Buy the English version and get the Spanish version for 50% off. A savings of $2,100.00!!!!!!!

FDA Survival Kits
Buy one of our Survival Kits and get one hour telephone consultation with the developer/author absolutely FREE. A $500 value!!!!!

Web seminars
Buy three of our archived web seminars, and get the fourth one FREE! You get the MP3 file (or CD) of the audio program and all handout files for each program. A savings of $397.00!!!!!!

Call us at 714-289-1233 to take advantage of these fantastic savings!


Upcoming workshops

Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA

Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23
Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

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