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CPhI released Part 2 of its annual industry report focused on the future of the pharmaceutical industry.
CPhI Worldwide released the first part of its second annual report, which included three industry experts discussing their predictions for the future of the pharmaceutical industry. The experts included Prabir Basu, consultant at Pharma Manufacturing; Emil Ciurczak, president at Doramaxx Consulting; and Brian Carlin, director open innovation at FMC.
Over the next five years, the pharmaceutical industry will need to implement new approaches to advance manufacturing. Basu suggests that the industry needs to adopt a more open R&D mindset, with a “Pharmaceutical Technology Commons” that will allow and encourage companies to share internal technology and knowledge more freely. It is apparent that many pharma companies do not have access to technology and developments that are available to other manufacturers, causing them to know “what to do” but not “how to do it” while maintaining quality and efficiency.
Ciurczak comments that the process stream within the pharma industry is antiquated, but now that the PAT Guidance in the US is complete, we have a better understanding about how to improve the process stream. The problem? Many companies are not willing or able to accept the changes that need to be made to improve their business model. Ciurczak explains that Quality by Design (QbD) will be integral to helping companies modify their raw materials processes. New technology can streamline the blending and granulation processes, and testing should be introduced into the tableting process through the use of near-infrared, Raman, and LIF technologies.
Basu also emphasizes the need for more stringent QbD expectations, stating that “Quality by Inspection” needs to be replaced by “Quality by Design” and should be taught to industry professionals in product development and manufacturing roles. “Quality should be built into a product with a thorough understanding of the product and the process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how to best mitigate those risks,” Basu states in the report.
Similarly, Carlin explained that in the future, the idea of “Quality by Inspection is no more appropriate to marketing applications than to pharmaceutical production… (rather), look at the quality of the manufacturing, such as the FDA quality metrics initiative to support risk-based inspection as per FDASIA sections 704 to 706.” He continues by saying that in the case of the future of excipients, an “increased understanding of complex systems under QbD may require novel attribute combinations not achievable from the separate components.”