There can be no doubt that the last decade for the pharmaceutical and biotech industry has been full of extraordinary change. Regulatory changes culminating in the FDA’s 2004 guidance A Risk-based Approach to CGMPs underscored the reality that as an industry we needed to evolve.
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Chatterjee discusses the factors driving China’s transformation from low-cost manufacturing to more sophisticated quality matters.
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As the U.S. pharmaceutical and biotechnology markets ebb and flow, one truth cannot be argued: sustainability is the provenance of companies that can adapt to the new marketplace and deliver on business performance.
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There is an old saying that “change is inevitable… adapting to change is unavoidable; it’show you do it that sets you together or apart.”1 Looking closely at how we have developed products, defined quality assurance and demonstrated regulatory compliance, the last five
years have been remarkable in terms of coping with change.
After a recent trip to China, I returned more impressed than ever with the rapid level of development within the major markets there. The maturity of the infrastructure in place, ready to support global commerce, was something I was not expecting.
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It is an interesting proposition: define what drug manufacturing will look like 20 years from now. There has never been a time when the portent for change has been so imminent.
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Its time to move the Visual Factory from the shop floor to the boardroom.
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Those who embrace the new process validation guidance may separate themselves from those who do not.
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Biopharmaceutical companies should come together to create an efficient business continuity plan that would be effective in a pandemic.
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