Sundar Ramanan
The FDA has recently updated their guidance on Continuous Manufacturing of Drug Substances and Drug Products. The ICH Q13 guidance is an all-encompassing framework for addressing key Quality Compliance questions on Continuous Manufacturing such as batch definition, control strategy, PAT, RTRT, while also providing structure for including Process Modeling in the Regulatory Submission. The FDA issuance of ICH Q13 as a final guidance will accelerate the industry transition from a traditional fed-batch process to modern Continuous Manufacturing.