A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

Leane, Michael, Pitt, Kendal, Reynolds, Gavin and , The Manufacturing Classification System (MCS) Working Group (2015) A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms. Pharmaceutical Development and Technology, 20 (1). pp. 12-21. ISSN 1083-7450

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Abstract

This paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and subsequent discussion within APS focus groups and the MCS working party. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulation. It has many applications in pharmaceutical development, in particular, it will provide a common understanding of risk by defining what the "right particles"are, enable the selection of the best process, and aid subsequent transfer to manufacturing. The ultimate aim is one of prediction of product developability and processability based upon previous experience. This paper is intended to stimulate contribution from a broad range of stakeholders to develop the MCS concept further and apply it to practice. In particular, opinions are sought on what API properties are important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. Feedback can be given by replying to our dedicated e-mail address (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.

Item Type: Article
Uncontrolled Keywords: drug product manufacturing processes,oral solid dosage forms,pharmaceutical development,quality by design,robustness,pharmaceutical science ,/dk/atira/pure/subjectarea/asjc/3000/3003
Faculty \ School: Faculty of Science > School of Pharmacy
Related URLs:
Depositing User: LivePure Connector
Date Deposited: 09 Jul 2021 07:28
Last Modified: 28 Jul 2021 00:42
URI: https://ueaeprints.uea.ac.uk/id/eprint/80450
DOI: 10.3109/10837450.2014.954728

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