CPhI expert warns without urgent regulatory change improving quality is a fool's game

CPhI Worldwide, organized by UBM EMEA, launches part i of its annual report ahead of CPhI Worldwide 2015 in Madrid (October 13-15) – as CPhI expert Girish Malhotra calls for a radical solution to improve pharma manufacturing processes.

He argues that, for far too long, we have allowed the status quo to continue, and that for true continual improvement we need to make it easier for companies to make vital alterations to manufacturing processes, without being hindered by a full re-approval process.

Under his guidelines the pharmaceutical industry will be allowed to commercialize process improvements (yield, process/operating conditions, operating parameters, cycle time) in the manufacture of approved APIs and their formulations. Guarantees on quality will then be provided from the manufacturing company, and they must ensure that the product efficacy and performance will not lessen, and the product will be equal to or better than the approved product produced by the company.