FDA to Provide Special Help to Manufacturers with New Technology 
​[Posted on: Thursday, December 1, 2016]

In the last few years, the drug manufacturing technology has been going through steep modernization. Some developments are simpler and logical such as use of single-use systems, while others are more complex such as 3D-printed drugs, continuous manufacturing systems, and robotic manufacturing systems. Manufacturers need additional help from FDA to assure continued compliance. Recently FDA created an Emerging Technology Team (ETT) specifically to assist companies all through their development phase till market approval for such technologies. About two-thirds of drug shortages and recalls are due to GMP issues. These issues occur across all kinds of drug and biological products. Last year, FDA created a special super office to oversee manufacturing quality issues called the Office of Pharmaceutical Quality (OPQ), and within it created 8 sub-offices to address the various quality-related issues. One of the main functions of OPQ is to get involved in CMC issues early on in the development of new drug and biotech products, particularly those using new technology. Manufacturers can directly approach the ETT staff to discuss production, characterization, facility design, and any other issues critical to them. New technologies are defined as those for which FDA has limited experience with. For such manufacturing technologies, the ETT staff expects to inspect the facilities early on, even before operations have initiated, and conduct ongoing review during the various phases of development. The OPQ and ETT staff has the mandate to act as co-lead reviewers and trouble-shoot any issues with review division to facilitate smooth development and market approval of products manufactured using novel technologies. From the perspective of sponsors, this provides a unique opportunity to discuss innovative manufacturing technologies early on with the FDA before embarking on expensive and risky development. The science of manufacturing has come a long way but many regulations and guidance documents, along with established industry practices still use technologies from decades past. Due to the increased complexity of manufacturing operations, the drug supply chains are increasingly at risk of interruption for quality issues as the recent experience has demonstrated. Being able to discuss and troubleshoot new methods for manufacturing early on directly with the relevant experts at FDA is a significant incentive for developers to experiment with modernization of the supply chain. Hopefully, more and more manufacturers will take advantage of this increased access to FDA.