Just read Mina Kime's 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. 

At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

Genzyme is likely to enter into a Consent Decree with FDA over ongoing cGMP problems at its Allston facility. The company says that FDA plans enforcement action.  Here, reporting from Wall Street Journal today. Blogger Jim Edwards notes a 14-year history of compliance issues at Genzyme on his blog today.

This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered the use of PAT at AstraZeneca in Europe.

The compliance consultants, Vectech, are now offering virtual cGMP consulting services, to help drug manufacturers deal with FDA compliance questions immediately via videoconferencing. The company is promoting this as a way to eliminate travel costs, yet ensure "face time." Costs are said to be a fraction of what traditional consulting runs. For more, read on.

FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."

But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?

Some of those in favor of relaxed reimportation often argue that the drug industry is fear mongering when it points to potential safety problems with drugs or ingredients sourced from abroad. "Be afraid, be very afraid. "  Well, recent events have shown that there is reason for fear....or at least for extreme caution when ensuring the pedigree of any raw materials  sourced from abroad. 

Computer documents have been the downfall of many a company---think Enron.  And things as basic as date and author stamps and wording became very important in Merck's Vioxx case.

In its neverending fight against both poor manufacturing practices and the manufacture and marketing of unapproved drugs, FDA has filed a Consent Decree and expects courts to prohibit Activis’ Totowa, New Jersey facility from further production.

Last week posed a scheduling quandary for anyone interested in Pharmaceutical Quality by Design and Process Analytical Technologies.  Three important meetings were taking place....of course, the AAPS annual meeting in Atlanta, but also the Eastern Analytical Symposium and....the American Institute of Chemical Engineers meeting in Philadelphia.