Wednesday, November 30, 2005

FDA issues Consent Decree to California Company

FDA announced on November 29 that MBI Distributing, Inc. (MBI), also known as Molecular Biologics, an OTC drug manufacturer of eye drops and other products, has signed a consent decree that requires it to cease manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations at its Benicia, California facility.

This action is a result of FDA having determined that the firm has been manufacturing eye drops in a manner that does not conform to FDA's current good manufacturing practice requirements. The firm has not corrected violations noted during inspections, despite Agency efforts to have the company achieve compliance.


Among other things, at FDA's most recent inspection, the firm lacked manufacturing controls to ensure that its eye drops were sterile.

Here's another example of what can happen when GMP is not applied and followed.

Read FDA's Press Release with more information about this action.
Go to
www.GMPTrainingSystems.com

Click on Resources, then scroll down to Timely Resource Articles.

Training Tip

During your GMP training sessions, have small groups of people discuss the impact an action like this can have on a company.

Answers may include things like:

- Stock price drops (causing stockholders to get cranky and put pressure on management to improve performance).
- Reputation of the company is affected, possibly resulting in decreased sales.
- Lost revenue and possibly lost jobs.
- Budget tightening at the company.
- More FDA scrutiny.
- Morale could decrease within the company.


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www.GMPTrainingSystems.com


Tuesday, November 08, 2005

After Action Reviews - The Road to Problem Prevention

An After Action Review is an assessment conducted after a project or major activity that allows employees and leaders discover (learn) what happened and why. It may be thought of as a professional discussion of an event that enables employees to understand why things happened during the progression of the process and to learn from that experience.

Conducting an After Action Review is particularly useful after a GMP violation is noted, either by a formal or informal internal audit, or by an FDA inspector.

Here are some questions to help you conduct an effective After Action Review.

  • What happened?
  • What factors most contributed to the event?
  • What was the genesis or root cause of the event?
  • Was there a "turning point" in causing this to occur? If so, what was it?
  • What did the organization fail to do in picking up any signals that may have alerted us to the problem before it occurred?
  • Did our organizational culture lead us in this direction?
  • What did our organization do correctly, in terms of responding?
  • Can this problem re-occur?
  • What can we do to prevent this from happening again?
  • How can we make this prevention action a priority?

This method - an After Action Review - can help you make progress in Problem Prevention.

Read David Markovitz' latest article - Problem Solving is Not Good Enough: Problem Prevention is the Key to Success.

Find the article at http://www.gmptrainingsystems.com/asp/articles.asp

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