A nice article with good suggestions and challenges to implement.
Blogs | Chem.Info | Top 10 Ways to Make GMP Training Relevant:
"There is nothing that could be more exciting and fulfilling than being part of a dynamic training group that equips its organization to be a finely tuned work force of scholars that embrace GMPs as a business enabler.
Unfortunately, rather than a graduate education in the pharmaceutics of regulations, our best and brightest are subjected to a mind-dulling deck of tired old PowerPoint slides.
Frankly, the problem is endemic and here's why:" . . .
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The FDA is responding with plans to globalize its own operations by working out mutual inspection pacts with other nations and inspecting imports based on the likelihood that a particular drug has been tampered with.
The FDA should have the power to go after counterfeit drugs - Sentinel Source.com: Guest:
"In some countries, 30 percent to 50 percent of medications are counterfeit — unlicensed knockoffs or imitations of real drugs. A new study published in the June 2012 edition of the Lancet found that about a third of the anti-malaria drugs administered in Southeast Asia and sub- Saharan Africa were either counterfeit or so poorly made that they were ineffective.
In the United States, the problem of counterfeit drugs is still relatively rare, but growing. In February, a counterfeit version of the cancer drug Avastin that contained none of the active ingredient was purchased online by various medical groups that were ignorant of the fakery."
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The original link broke.
You can still read about the same topic here:
How FDA and ISMP Utilize Medication Error Reports to Improve Drug Safety - FDA.gov
Learn more details about these companies, and why they received warning letters.
Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies - RAPS - News - Article View:
"The US Food and Drug Administration’s (FDA) newest batch of warning letters was released on 29 May 2012, and some familiar faces have come under further scrutiny.
Medical device manufacturer McNeil PPC, a subsidiary of Johnson & Johnson, was hit with a lengthy list of claims by FDA, which said the firm is manufacturing no fewer than ten adulterated products. Three of the company’s Pennsylvania facilities are currently the subject of an FDA consent decree after the facilities repeatedly experienced manufacturing deficiencies and “several extensive recalls.” The company’s recent warning letter is extensive enough to draw parallels to the deficiencies which lead to the consent decree.
Medical device manufacturers Advanced OrthoPro Incorporated and Lebanon Corporation Incorporated also received citations for Quality System Regulation (QSR) deficiencies, while tissue bank company Gramercy Fertility Services was found to have violated human cells, tissues and cellular and tissue-based product (HCT/P) regulations."
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