GMP Risk Management In New Drug Contract Research Organization (CRO)

The pharmaceutical industry is significantly valuable to both economy and the society. New drug R&D, the drive force for the sound development of the industry, plays a decisive role in the future of pharmaceutical industry. However, new drug R&D is always a hot topic among people who have interest in it due to its characteristics such as long term, big investment, as well as high risk. The risks in new drug R&D include financial risk, technology risk, management risk, manufacturing risk, market risk and environmental risk. As the most important developing country and the largest pharmaceutical market, China attaches great importance to pharmaceutical industry, and offers many preferential policies for new drug R&D. In China, the level of R&D is far behind the developed countries including US, EU and Japan in terms of investment, system, talents and administration, outstandingly, lack of expertise in project management results in resource waste, brain drain and lagged progress. Contract Research Organization or CRO, an emerging sub-sector of the industry, rises in Europe and US, enters into China, and becomes a solid support for local pharmaceutical companies in new drug R&D. The cooperation between pharmaceutical companies and CROs to reduce project risks has become a new topic for researches in new drug R&D. The quality of drug is related with design, manufacture, and analysis. Quality by design is well accepted in this industry. Therefore the philosophy of GMP should be well adopted in R&D. This paper analyzes various kinds of risks faced by a pharmaceutical company in R&D, and how to take advantages of CRO to avoid or reduce those risks. An example is used to explain risks that deserve attention and the ways to tackle the same at different R&D stages. This example, as a common project in nowadays industry, has reached a milestone achievement, and will become guidance for similar projects.