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.
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."
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.
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.
Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis. And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W.
Sandoz's Wilson, NC, plant received an August 12 483 from FDA over failure to use proper validation measures for testing lots of its beta-blocker Metoprolol Succinate ER tablets. FDA writes: a) Failures were noted in the process validation studies performed on the Metoprolol Succinate ER 50 mg tablets.
At the American Chemical Society national conference last weekend, Rensselaer Polytechnic researcher Dr. Robert Linhart announced that his team may have built the first fully synthetic heparin. Whether or not you believe that the possibility of another contamination crisis of natural raw heparin exists, the potential for a heparin supply...