The U.S. life sciences industry is a business sector which faces the significant task of developing, testing and manufacturing pharmaceuticals.  Due to the complex environment in which pharmaceuticals are developed, there is a strong need for IS and other quality systems to monitor, manage and control the production processes.  The quality systems can drive each of the steps with the product life cycle and is a critical factor for guaranteeing that the optimum quality standards are met.

The FDA plays an important role in this systematic testing process by applying rigorous oversight to the pharmaceutical industry, to ensure high quality standards, efficacy, and the safety that the general public demands.  Throughout the research, development, and the manufacturing life cycle of drugs, vaccines, and other biopharmaceutical products, the FDA’s role is that of a principal supervisory agency.  Their job is to assure that optimum quality is being achieved, and the best practices are being followed.

So how can you prepare your bio-pharmaceutical company for one of these surprise inspections?  Well, one thing you can do is to hire a life sciences consulting firm that specializes in the development of quality systems, in which they can design, or redesign your entire system, to meet FDA regulations.  The FDA uses it’s oversight to guarantee that such issues and problems with contaminants and failed processes are quickly sniffed out and identified.  Without the help of an experienced consulting firm, your company may fail to take the preventive actions necessary to successfully pass an FDA audit.  Because of the severity of the consequences in developing possible faulty pharmaceutical products, the FDA has very little tolerance for variability or deviation from its quality inspection regulations.  This means if your products do not pass this FDA quality inspection, you will be shut down, and shut down fast.

The pharmaceutical industry, like any traditional manufacturing industry, uses traditional, older production processes and many companies have outdated information systems.  In the past, the work flow in the pharmaceutical industry was optimized for straightforward production including cost reductions, rather than focusing on transparency and quality production.  Furthermore, even though many pharmaceutical companies are starting to catch up to the rest of the manufacturing industry, and have begun to develop more sophisticated systems, many companies wouldn’t be able to pass a simple FDA regulatory inspection if they had to.  If you want your company to be properly prepared, talk to a pharmaceutical consulting firm that specializes in quality control, and they will be able to prepare your company properly in case of a surprise FDA inspection in your company’s future.

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