Pharmaceutical Regulatory Affairs and IPR

The chemical industry has looked at the use of continuous reactions for many years. In fact, the only industry sector not involved in continuous chemistry has been the manufacturing of pharmaceutical ingredients. More recently, the manufacturing of API’s has seen a push into continuous chemistry and the FDA is helping to lead the charge. However, from a regulatory point of view, we may see a major switch in how we produce our products. The concept of a batch will change dramatically and the requirements for validation will need to be adaptive to a new manufacturing paradigm. In addition, the switch to continuous reactions could benefit the overall economic and safety of drug production. This presentation will look at the issues around manufacturing API’s and the regulatory changes required moving from batch to continuous. The presentation will focus on the definition of the batch and the critical parameters working in continuous reactions.