28/29 April 2021
In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline on continuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline entitled "ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products" by means of the final version of the concept paper. As the title suggests, the new guideline addresses the manufacturing of both drug substances and drug products. To contribute to a general understanding and harmonisation, ICH Q13 will include many definitions such as: startup/shutdown, state of control, process validation, continuous process verification, etc.
Key elements of the new paper are: system dynamics, monitoring frequency, detection and removal of non-conforming material, material traceability, process models and process controls.Moreover, the document will also provide information about products registration: small molecules as well therapeutic proteins are explicitly named, which means that biopharmaceutical processes will also be in the scope of the guideline. Dr Sau Lee (FDA, United States) will be rapporteur of the working group and Dr Yoshihiro Matsuda from the Japanese Authority (MHLW/PMDA), regulatory chair.
The elaboration of the paper is planned to take three years.
You can download the final concept paper entitled "ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products" on the ICH website.