Monday, February 27, 2006

FDA proposes controversial change in GMP

In mid-January 2006, FDA issued a proposed rule exempting phase I investigational drugs and biologics for human clinical trials from the requirement to follow CGMP regulations. FDA has issued a brief guidance with GMP recommendations for phase I (to replace the CGMP regulation), and a direct final rule to make the change in the event that they receive no significant adverse comments.

The proposed draft GMP guidance is highly controversial, particularly in terms of patient safety, product release, and facility, testing, and training requirements. Furthermore, it does not harmonize with European Union requirements.

Go to www.GMPTrainingSystems.com and click on Resources. Scroll down to INDs - CGMPs During Phase I Clinical Trials. Here you will find the Proposed Rule, the Direct Final Rule, and a new Guidance Document.

Comments are due to FDA by April 3, 2006.

Audio Seminar set for March 9.

We have arranged an Audio Seminar to discuss this proposal by FDA. Barbara Immel, Editorial Advisory Board Member for BioPharm International and Editor of The Immel Report, will lead the discussion at this important session. David Markovitz, President of GMP Training Systems, Inc., will be the Moderator.

Learn more about this Audio Seminar at www.GMPTrainingSystems.com. Click on Audio Seminars and find the session titled Chipping Away at the GMPs.

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

Tuesday, February 07, 2006

FDA Slams the Door on New Jersey Company

FDA issued an Order to Cease Manufacturing to BioMedical Tissue Services Ltd. last week. Read this six page letter outlining their violations. Note they define "manufacturing" to mean any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cells, tissues, and cellular and tissue-based products (HCT/Ps), and the screening or testing of the HCT/P donor.

Find this letter at http://www.gmptrainingsystems.com/asp/resources.asp
Jump to Timely Resource Articles.

Training Tip

Use this article in your GMP training to point out the consequences of non-compliance.

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

We are offering a wide array of audio seminars. Check our website for upcoming topics.

Thursday, February 02, 2006

FDA Enforcement Report

FDA issues a weekly Enforcement Report. This document contains very useful information that we can use in our GMP Training sessions. For instance, in the February 1, 2006 Enforcement Report, some of the reasons for product recalls include:
  • Contamination
  • Mislabeling
  • Lack of validation
  • Short fill volumes
  • Illegible lot numbers and expiration dates
  • Incorrect lot numbers and expiration dates
  • Incorrect components in the package
Training Tip

Print the FDA Enforcement Report and make copies for those participating in GMP training sessions. Have them list all of the reasons for product recalls and discuss what procedures you have in place to prevent these things from occurring at your company. Then stress the importance of following those procedures. Conduct a discussion of all the costs associated with these product failures and recalls.

Key learning point: Prevention is the key to success.

You can download FDA's February 1 Enforcement Report here
www.GMPTrainingSystems.com/asp/resources.asp
Scroll down to FDA Resources

GMP Training Systems, Inc.
Experience You Can Trust!
www.GMPTrainingSystems.com

Our next GMP Boot Camp is scheduled for April 5 - 6 in the Anaheim/Newport Beach (California) area. These fill up fast. Call us at 714-289-1233 to reserve your place.