«The proposal coming from the Manufacturing classification system (MCS) working group represents a “guideline” for the formulator, that might be used as far as possible adapting it to the specific active ingredient to be formulated and inserting its description into the pharmaceutical development section of the dossier».
Piero Iamartino coordinates the new AFI’s Pharmaceutical Technology working group, together with professor Andrea Gazzaniga of the University of Milan. He summarizes for Pharma World the history and final goals of the MCS initiative, originally proposed in 2014 by a British university-industry mixed working group led by representatives of three big pharma, Bristol-Myers Squibb, GlaxoSmithKline and AstraZeneca. AFI’s Pharmaceutical Technology group accepted the invitation of the authors of the paper published in Pharmaceutical Development and Technology1 aimed to review the potential of the proposed approach and how it could benefit the pharmaceutical industry.
«The introduction of a manufacturing classification system could help explain the quality-by-design approach to the regulatory authorities, highlighting that the manufacturing process has been developed taking into account quality criteria and the critical quality attributes of the active ingredient. The MCS would have no direct impact from the regulatory point of view: it would rather enrich the knowledge of the formulator, to be briefly explained in the dossier», explains Iamartino.