We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is requiring that drugmakers adopt quality systems thinking, something that the industry finds challenging to do on a systematic basis. In fiscal 2006, these difficulties led the FDA to declare no fewer than 45 Class I drug recalls for significant violations that threatened consumer health and safety. Experts say that pharmaceutical companies are leaving themselves open to such problems by failing to thoroughly investigate how quality control failures occur so that they can make needed top-to-bottom changes. A scientific approach is required for this to work, and upper management must be convinced that big money is at stake. Preventive action is also necessary; following the FDA’s comprehensive current good manufacturing practice guidelines and using quality by design techniques can help avert the need to lock the barn doors after the horse has already bolted. Strict change-control systems can ensure that alterations in production lines do not result in quality suffering. Finally, the software used in drug manufacturing must be validated just as much as the actual drug production line. This edition of The Food and Drug Letter looks at the FDA’s current thinking on quality issues and what experts are advising the industry to do to comply with the regulations.