| The U.S. life sciences industry is a business sector | | | | fail to take the preventive actions necessary to |
| which faces the significant task of developing, | | | | successfully pass an FDA audit. Because of the |
| testing and manufacturing pharmaceuticals. Due to | | | | severity of the consequences in developing |
| the complex environment in which pharmaceuticals | | | | possible faulty pharmaceutical products, the FDA |
| are developed, there is a strong need for IS and | | | | has very little tolerance for variability or deviation |
| other quality systems to monitor, manage and | | | | from its quality inspection regulations. This means |
| control the production processes. The quality | | | | if your products do not pass this FDA quality |
| systems can drive each of the steps with the | | | | inspection, you will be shut down, and shut down |
| product life cycle and is a critical factor for | | | | fast. |
| guaranteeing that the optimum quality standards | | | | The pharmaceutical industry, like any traditional |
| are met. | | | | manufacturing industry, uses traditional, older |
| The FDA plays an important role in this | | | | production processes and many companies have |
| systematic testing process by applying rigorous | | | | outdated information systems. In the past, the |
| oversight to the pharmaceutical industry, to | | | | work flow in the pharmaceutical industry was |
| ensure high quality standards, efficacy, and the | | | | optimized for straightforward production including |
| safety that the general public demands. | | | | cost reductions, rather than focusing on |
| Throughout the research, development, and the | | | | transparency and quality production. Furthermore, |
| manufacturing life cycle of drugs, vaccines, and | | | | even though many pharmaceutical companies are |
| other biopharmaceutical products, the FDA's role is | | | | starting to catch up to the rest of the |
| that of a principal supervisory agency. Their job is | | | | manufacturing industry, and have begun to |
| to assure that optimum quality is being achieved, | | | | develop more sophisticated systems, many |
| and the best practices are being followed. | | | | companies wouldn't be able to pass a simple FDA |
| So how can you prepare your bio-pharmaceutical | | | | regulatory inspection if they had to. If you want |
| company for one of these surprise inspections? | | | | your company to be properly prepared, talk to a |
| Well, one thing you can do is to hire a life sciences | | | | pharmaceutical consulting firm that specializes in |
| consulting firm that specializes in the development | | | | quality control, and they will be able to prepare |
| of quality systems, in which they can design, or | | | | your company properly in case of a surprise FDA |
| redesign your entire system, to meet FDA | | | | inspection in your company's future. |
| regulations. The FDA uses it's oversight to | | | | If you enjoyed this article about a life sciences |
| guarantee that such issues and problems with | | | | consulting firm, please feel free to post it to your |
| contaminants and failed processes are quickly | | | | site or blog and forward this link to your friends. |
| sniffed out and identified. Without the help of an | | | | Have a great day! |
| experienced consulting firm, your company may | | | | |