FDA Pushing Ahead with Quality by Design (QbD) Developments

With the goal of pushing ahead with the QbD initiative and thus the scientific approach in the context of pharmaceutical process development, the US-American health authority FDA made a contract with the National Institute for Pharmaceutical Technology (NIPTE) for 1,19 million US$. It is intended to have evaluated in the given time frame (until September 2010) how and how far pharmaceutical process- and quality controls and the efficiency of the production can be improved and how further requirements regarding Quality by Design can be derived from the results. These are to be published after completion of the studies and ideally to be used for the creation of new guidance documents.