Yet another Indian drug manufacturer was reprimanded by US regulators for a variety of serious quality-control infractions. But this particular episode may resonate wider than most because the company also makes products for still other manufacturers, but failed to notify them of the problems.
And the problems were extensive. The US Food and Drug Administration cited Sri Krishna Pharmaceuticals for numerous issues concerning data integrity that involved laboratory records, computer systems, validating processes, and manipulating records of batches of drugs.
Overall, the FDA said Sri Krishna failed to establish adequate written procedures to assure manufactured drugs have the stated strength, quality, and purity. The agency found the violations during a December 2014 inspection, but the company failed to sufficiently correct the problems, according to an April 1 warning letter that was sent to the drug maker and posted this week on the FDA web site.
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This is appauling; however, not a surprise. It is imperative that adequate vendor qualification be conducted not only prior to the utilization of any third parties products or services but also ongoing throughout the conduct of these operations. Furthermore, firms operating in our industry need to understand that it is ultimately their responsibility to ensure that the products/services outsourced are what they purport to be and produced under a validated and verifiably compliant quality management system. While the business mind might only see this as a means of reducing production cost, the cost of non compliance and risk to the overall integrity of the product and, most importantly, the patients use of the product, out ways any “assumed profit margin increase” that could have been the rationale for outsourcing to a firm with a history of noncompliance. I am a proud regulatory compliance expert but my entrance into the love of navigating the Regulatory pipeline came out of my being a scientist and product entrepreneur first. Compliance it’s not just the law, it’s also good business. I challenge my colleagues and any opposition to take this whole heartedly and advance the standard rather than take the risk and be yet another statistic.
A wonderful surprise to see that comments have been added back to the Pharmalot! What’s 5 months and a week?