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.

Getting some good news for a change, Johnson & Johnson ranks fourth among all companies in Newsweek's annual Green Rankings, ahead of other pharmaceuticals that made the top 100, including: Baxter, BMS, Allergan, Pfizer, Abbott, Lilly, Merck, and Hospira. To see how various drug makers fared among the top 500, use the drop-down menu on the link above to locate the pharmaceutical sector standings.

--PWT

Drug manufacturers have been coming to grips with how to leverage social media, from Tweets to blogs, without overstepping the bounds of compliance. Johnson & Johnson and a number of companies have taken the lead, as our Senior Editor for Digital Media Michele Vaccarello Wagner has written.

Just read Mina Kimes' enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's.

Newsweek has just released its list of the 500 greenest companies, including sector breakdowns. Here are the top pharma companies, headed up by J&J (number 3 overall) and Bristol-Myers Squibb.

No one is tracking pharma's social media presence better than WhyDotPharma, and the site/blog has done a nice review of which pharma companies are Twittering the most (Amgen, Boehringer, JNJ, Genentech), and how they're doing it. Some companies are using Twitter to establish a presence and get the word out on corporate news and policies, while others are using Twitter to follow and see what's being said about themselves and the industry.

Paul D’Eramo—former ISPE chair, a two-decade veteran of FDA, and current head of Quality and Compliance Worldwide for Johnson & Johnson—always has a finger on the pulse of the regulatory environment, and knows that GMPs are fluid, not static. “We are always searching for what the ‘c’ in cGMP is,” he says.

At October’s ISPE 2008 show in Boca Raton, Florida, D’Eramo offered his take on current trends that are shaping GMPs. Though not surprising, his are the words of experience and insight:

If you put credence in Swiss firm Covalence's annual ethics rankings, yes, GSK, BMS, and J&J are the most ethical companies in the Pharmaceuticals and Biotech sector. The list looks like this:

1. GSK

2. BMS

3. J&J

4. Abbott

5. Novartis

6. Roche

7. Boehringer Ingelheim

8. Astra Zeneca

9. Pfizer

A nice discussion recently on BNET with J&J's Joe Natale, who is heading up J&J's first foray into website entrepreneurship.

The past few months have seen renewed vigor from FDA's DDMAC (Division of Drug Marketing, Advertising, and Communications) in scrutinizing manufacturers' claims of safety and efficacy. In particular, DDMAC has cracked down on makers and marketers of ADHD medications for their alleged false and misleading claims.