Regulators should know their place in pharma manufacturing, expert says
The submission of a manufacturing expert that forms part of the CPhI Annual Industry Report 2018 says that regulators should stick to the task of assuring quality to allow innovation to bring process improvements.
Girish Malhotra, president at EPCOT International, a company focused on simplifying operations and improving technology in manufacturing, has written that pharma companies are in danger of becoming stuck in a rut, where their approach is only to meet regulations and not to consider the potential of process improvements.
He calls for regulators to enable a manufacturing technology innovation environment by shortening approval time to three months.
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