Helena Champion - Ensuring Drug Quality in a Global Economy

Version 1

      Publication Details (including relevant citation   information):

      Contract   Pharma May 2014.

      Abstract:

        Conventional economic wisdom holds that drugs, both branded and   generic, can be made by low cost providers, assuming that   products will be good enough quality to treat a patient. The   reality is that it takes enormous and complex effort by a   manufacturer to follow Good Manufacturing Practices (GMP) to   achieve drug safety and effectiveness.

        While some companies focus on quality, many drug companies and   drug stores have switched to low cost manufacturers and have not   monitored or supervised their performance properly, resulting in   low quality, unsafe drugs and drug recalls. Many companies use   English speaking auditors to audit suppliers who cannot   thoroughly evaluate foreign facilities.

        Companies that outsource should use the same standards auditing   all their suppliers before selection. This means auditors must be   very fluent in the supplier’s language, highly GMP trained and   very thorough. Auditors not fluent in the language are   inadequate, since reliance on translations prevents them from   seeing what is really happening and the accuracy of translation   is suspect. That is why the FDA and the European Medicines   Agency, who use inspectors fluent in the relevant languages,   often find fraudulent test and quality control data and so many   quality problems at these drug facilities, especially in India   and China.

        U.S. consumers don’t know if the drugs and dietary supplements   they buy are made properly, who made them and where or how they   were made. People trust a brand name, when in fact the product is   not made by that brand name owner, only distributed and marketed   by them. The name on the package is seldom that of the actual   manufacturer of the drug inside the package and the address is   very seldom that of the actual manufacturer.

        Consumers don't know that the manufacturer and marketer decide   whether or not a drug batch is good and there is no routine   independent testing. Consumers should know where their drugs are   made so they can make an informed decision.

      Address (URL): http://www.contractpharma.com/issues/2014-05-02/view_features/ensuring-drug-qual ity-in-a-global-economy/