Last December, after some delay, FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11 requirements. As such, the Agency is undertaking “add on” surveillance of manufacturers’ computer systems during the course of its regular inspections. At DIA 2011 in Chicago last week, FDA CDER’s George Smith, who heads up the Agency’s Part 11 working group, shared information on the status of these activities.

FDA’s Adverse Event Reporting System (AERS) is a database that allows physicians, patients, and others to call attention to post-marketing drug safety issues. Reporting in AERS is voluntary, and thus data far from reliable. Still, the statistics are used by FDA as a means of determining potential safety concerns of drugs on the market.

The release of ICH Q11 has been anticipated for some time now. The purpose of Q11 is to take the Quality by Design concepts mapped out in ICH Q8, Q9, and Q10 and apply them more clearly and specifically to the development and manufacture of drug substances (as opposed to drug products). And so the release of the draft document is a cause for fanfare.

The Atlantic, one of the oldest and most respected magazines around, has just come out with an article titled, "The Triumph of New-Age Medicine." In it, author David Freedman takes issue with those who would call new-age or alternative medicine "cleverly marketed, dangerous quackery."

The most popular piece of content on PharmaManufacturing.com for the past month or so has been "Pfizer Reinvents Lean in the Lab," an in-depth look at how the QA/QC labs in the company's Grange Castle, Ireland, site, have revamped and "Leaned" their work habits.

More positive Janssen news, the release of a documentary on an important subject.  "Living With Schizophrenia" is nicely produced but a bit too choppy (interview clips laid out one after another, instead of following each individual in sequence).

Watch it here.

Traces of the wood preservative TBA (2,4,6-tribromoanisole) have reportedly been found in batches of the HIV medication Prezista, manufactured by Janssen Cilag, a J&J subsidiary. according to a news report in the U.K. publication, Pink Paper. So far, five batches have been recalled. 
The countries affected include Austria, Canada, Germany, Ireland and the United Kingdom. In the UK only Prezista 400mg is affected.

The Los Angeles Times just ran an editorial this week that caught my eye, mentioning a paper published in the London School of Economics journal, BioSocieties.

This is old news by now, of course. The paper was published online back in February and was meant, not as a groundbreaking study, but as a thought provoking piece designed to get readers to question the official numbers circulated by Tufts and PhRMA.

This week, USP officially launched a public database of information collected on the quality of drugs from 8,700 records of tested samples from Ghana, Laos, Vietnam, Cambodia, the Philippines, Thailand, Peru, Guyana, and Columbia. The database is part of the USAID-supported Promoting the Quality of Medicines (PQM) program

Data collected through 2010 shows, for example, that 4.6 % of all drugs tested in Africa, Southeast Asia and Latin America failed PQM’s quality tests, with antimalarials the primary target.

Last week brought news that Teva and consumer goods giant P&G will be partnering, combining their over-the-counter pharma businesses outside of North America.  In February, Fuji and Samsung made moves in biopharm and biogenerics.  P&G has core pharma businesses but is still primarily known as a consumer goods company, fitting the prediction that &quo