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

Michael Leane, Kendal Pitt, Gavin Reynolds, Manufacturing Classification System (MCS) Working Group

Research output: Contribution to journalReview articlepeer-review

133 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)12-21
Number of pages10
JournalPharmaceutical Development and Technology
Volume20
Issue number1
Early online date27 Aug 2014
DOIs
Publication statusPublished - 2015

Keywords

  • Drug product manufacturing processes
  • Oral solid dosage forms
  • Pharmaceutical development
  • Quality by design
  • Robustness

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