Good Manufacturing Practices
Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals are set forth in federal regulations, FDA guidance, and informal FDA policy, affecting every aspect of drug manufacturing, storage, distribution, and labeling. The quality of a drug product can potentially be affected at any point, so there are standards for every part of the process.
The cGMP requirements are purportedly flexible to allow each manufacturer to decide individually how to best implement the necessary controls. A company should not only use scientifically sound design, processing methods, and testing procedures, but it should also be prepared to show records or reports to FDA to prove compliance.
FDA inspects pharmaceutical manufacturing facilities worldwide using individuals whose sole job it is to find any shortcomings in how companies are following the cGMPs. FDA also relies upon reports from the public and the industry about potentially defective drug products.
If FDA finds a company in violation of cGMP requirements, any drug the company makes could be considered “adulterated.” This doesn’t necessarily mean that the drug(s) are unsafe, but this declaration, if not disproved quickly, could be harmful to the company’s business and certainly prohibits the particular from being sold.
Many companies opt to voluntarily recall their drugs once this claim is made by FDA. FDA cannot force a recall, but it can bring a seizure or injunction case to court. The court can order federal officials to take possession of “adulterated” drugs and destroy them. FDA can also bring criminal cases, leading to fines and jail time.
The best path is to be compliant from the beginning, and to carefully avoid any appearance of non-compliance. The consultants and affiliated attorneys at FDAImports.com assist clients worldwide in complying with drug cGMPs.
