Ranbaxy, Wishful Thinking and the Fudge Factor

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?

It was educational to read the 483 that FDA issued to Ranbaxy's Ohm Laboratories on December 21, which was recently posted on FDA's web site. 

FDA's Jamaica, Queens, N.Y.-based inspectors found a number of interesting systemic problems at the Gloversville, N.Y. facility, including wishful thinking--in one case, instead of analyzing reasons for a failure, a hypothesis was advanced "there could be unidentified analytical error...." (I didn't think people could even try that kind of thing any more.)

Deficiencies in SOP's were also seen, as well as failure to perform adequate root cause analysis for equipment-induced problems. (Particles of foreign matter were reportedly introduced into bottles of medication...in one case, this was said to be caused by material flaking off filling machine nozzle seals--in another, by problems with packaging equipment, which may have caused particulates from cardboard boxes to be trapped within the bottles. For more, read on.)

Yes, it does cost money to install analytics, transfer data and to ensure that QC steps are taken. But how much does it cost not to do these things? Ranbaxy's already been under the compliance microscope for quite some time....As Ali Afnan of FDA has said in the past, it will ultimately be shareholders, not regulators, who push for smarter, better ways to handle compliance and QC. We already saw the beginning of this trend, with unusual shareholder interest in cGMP issues, with Genzyme this past summer. Will more companies get the message before it's too late?

These problems are surprising, since only a few years ago, in the pages of our magazine, Ranbaxy's top quality management asserted its commitment to ICH principles and such things as process analytical technologies.



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  • <p>Agnes:</p> <p>The last paragraph surprises me. Was it "smoke and mirrors"? When an "all liquid facility" can have the described problems, it tells me that the problems are more serious. If I read the citation right, protocol issues are cause of cencern. Similar issues were raised at the Indian facilities.  </p> <p>Daiichi Sankyo has their hands full.   </p> <p> Girish MALHOTRA </p> <p> EPCOT International </p>


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