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The FDA wants to create an electronic network to gather and share medical product safety information with healthcare professionals and patients, the agency announced.
The FDA warned WellSpring Pharmaceutical for a print advertisement the agency said was misleading and overstated the safety and effectiveness of its drug, including using inappropriate studies as supporting evidence.
Strict change-control systems are essential to protect customers from failed drug or biologic products, which makes good business sense for manufacturers.
The quality systems approach is as essential when making changes to pharmaceutical and medical device industry software as it is when changes are made to other aspects of the manufacturing process, experts said at a recent conference.
The FDA issued the final version of its comprehensive current good manufacturing practice (cGMP) guidance Sept. 29, making "no substantive changes" from the draft released two years ago, the agency said.
The FDA is now imposing the quality systems thinking that has been a staple of the medical device industry since 1997 on manufacturers of drugs and biologics, according to experts speaking at the recent Compliance Boot Camp in Las Vegas.
Perrigo recalled 11 million bottles of 500-mg acetaminophen caplets after its metal detectors revealed small metal fragments in some of the product, which it manufactured and distributed under various store brands.
The FDA's decision to issue 45 Class I recalls over the past fiscal year signals a fundamental shift in enforcement policy for an agency still reeling from criticism over recent drug safety incidents, experts say.
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.