New Delhi, August 29, 2018: Pharma’s future is putting innovations in the hands of innovators, not regulators – but we need to end the inertia before it’s too late Girish Market Predictions:
• Warns that in the next few years we will lose valuable process advances if regulators don’t stop dictating approaches
• We are seeing a ‘cultural dogma’ in pharma companies where their approach is only to meet regulations and companies become devoid of process advancements
• Foresees that, maybe, if given freedom by forward thinking pharma companies, CDMOs may have the incentives to innovate new process and manufacturing improvements and be a key part of the solution
• Is hopeful that if the regulators are listening in the next few years they will enable a manufacturing technology innovation environment, by shortening approval time to three months. That way commercial and financial considerations can dictate innovations – e.g. continuous manufacturing is an ongoing case in point.
Who is Responsible for Manufacturing Technology Innovation: Product Developer/Producer or the Regulator or the Equipment Supplier or the Contract Manufacturer Sometimes answer to a question exists and everyone is aware of the answer but is ignored for one self’s convenience. However, it is good to ask the question again to refresh and reinforce the existing and an established answer. We all know the answer to the question ‘Who is
responsible for the product quality and manufacturing process technology innovation for any product?’ Answer has been in front of us since the Stone Age. It is ‘the manufacturer and manufacturing process developer who is the creator of the product’. Other entities can, and do, assist in the process. But, I am revisiting the question and the answer to ensure that we all are on the same page. It is my perspective and not intended to question the creativity and imagination of any individual or entity. Readmore
Corporate Comm India(CCI Newswire)
