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Process Improvements Needed to Meet Global Pharma Demand
The CPhI Worldwide Pharma Insights report on Manufacturing indicates that while the industry is aware of the need to continue to improve manufacturing practices, processes, and efficiencies, the industry must more actively take the lead if vital changes driven through. The study was based on information provided via the CPhI website, in-depth surveys containing qualitative and quantitate information, and analysis from CPhI’s expert panel.
The inertia of the existing pharma model is impeding innovation and preventing wide spread adoption, the report says. Most of the sector now reports using continuous process improvements to drive efficiency savings, but more could be done to revolutionize practices.
CPhI findings show that 26% are using statistical process control, 21% using process capability analysis, 16% QbD, 12% Six Sigma and 11% using both lean/Kaizen and PAT. In addition, many are building for the future and making essential upgrades to existing equipment with 70% actively investing in manufacturing.
In the medium to long term, the industry should see a cross-pollination of process improvements from generics (where costs savings can still be made) though CMOs and ultimately into big pharma’s patented products, CPhI reports. The advantage here is that lower cost patented products would open huge new markets, while reducing the attractiveness of counterfeits.
For cost savings to be made however, the report clearly states further improvements must come from the industry itself and not the regulator.
“Not much will change in the current processes as the needed regulatory approval will come in the way of any improvement of existing processes. Success to exceed regulations will only come from process inception stage along with command of the process as they become commercial,” said CPhI panel member and President of EPCOT International Girish Malhotra. “Process centricity has to overtake the current ‘regulation centricity’ if pharma wants to see cost reductions in new and existing processes.”
According to the report, 59% of those surveyed plan to increase headcount this year; only 4% plan reductions. Outsourcing continues to see increases; 41% report that they are outsourcing more manufacturing. Nearly half of those surveyed stated they introduced more than three products last year, with a further 41% adding 1 to 3 products. The biggest manufacturing goals are to increase efficiencies and safety; 89% are testing raw materials sourced with compendial testing the most favored method (81%).