The Pharma industry has witnessed dynamic changes over the last few years, and outsourcing has been a popular way for pharma companies to improve.
FREMONT, CA: Unlike most of the products, consumers purchase consumers are oblivious of the quality of the drugs they consume. Most still believe that every drug is made by the company whose name is there on the label. In reality, 60 percent of pharma manufacturing is outsourced, as it helps the manufacturer in bettering operational efficiencies, expanding geographical presence, and enhancing the therapeutic expertise and on-demand services.
Outsourcing production enables pharma companies to focus on their core competencies, R&D, and marketing while leveraging CMO's focused expertise. On the contrary, the CMOs have different business objectives than the pharma companies, and as a result, are reluctant to embrace technology. Outsourcing production is expected to increase, but the industry observers are posing legitimate questions about how well CMO clients can supervise quality in their partnerships.
The pharma companies are currently seeking to mitigate their risks by completing an extensive due diligence process while selecting a CMO. Regardless of where it occurs, consumers should reasonably expect the drugs they take are manufactured using the best available technologies. Most of the information technologies that make up today's typical stack inclusive of ERP systems, manufacturing, process control, and lab information has been available since the 1980s. Add the explosion in capabilities the "digital revolution" has delivered in the interim. One would think that pharma, an industry whose lifeblood is innovation, would be at the forefront of technological advancement.
In this digital age, there is no reason pharma should not have the technology to ensure complete visibility into every aspect of manufacturing — whether it occurs in-house or thousands of miles away. Along with drums of product, pharma companies should require their CMOs to deliver a comprehensive electronic dataset that includes each operating detail.
Of course, Pharma 4.0 still represents a considerable challenge. The industry has not yet achieved Pharma 3.0, which would require drug companies to significantly modernize their facilities while insisting their CMOs do the same. That means the industry must necessarily implement Pharma 3.0 and Pharma 4.0 simultaneously. The transformation must begin in R&D's process development group and extend to a digital thread that provides complete traceability throughout the drug product lifecycle, whether the manufacturing assets are in-house or outsourced.
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