The manufacturing classification system (MCS)

The manufacturing classification system (MCS) is a successful joint APS collaboration between the Materials Science and Process Engineering and Product Formulation focus groups. It began in June 2013 after a joint meeting between the groups and expanded internationally enabling a wealth of discussion and knowledge to be captured.

The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of solid dosage forms based on selected properties of the active pharmaceutical ingredient (API) and the needs of the formulation. The proposed MCS could be used to develop a risk assessment for manufacturing and indicate how robust a manufacturing process is likely to be.

The initiative has resulted in two papers in Pharm Dev Technology ( 2015:20 (1) 12-21 and 2018:23 (10: 964-977). The concept has been presented at several national and international meetings to encourage active participation and discussion.

The most recent meeting was jointly run with the FIP as an on-line seminar on 26th January. The format included presentations, questions and panel discussion sessions. Over 150 people attended from around the world. The feedback was very positive with most participants gaining from the interactive sessions. Planning is ongoing for the next webinar and in particular to progress the MCS concept in Japan. If you wish to participate in the MCS initiative, then please contact