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Article / Jun 17, 2016

Quality Culture Wins Over Compliance

Pharma's Almanac, June 2016

The author (Guy Villax) presents his views about the latest update of FDA's guidance which includes quality culture.

It’s Official! FDA has introduced Quality Culture in its guidance – although still in draft, it signals a sea change at the agency. No longer will FDA focus solely on compliance. Pharmaceutical manufacturers will be recognized for excellent performance. Pharma companies that rely on contract service providers will be able to use Quality Metrics and New Inspection Protocol Project (NIPP) performance scoring to make better decisions when it comes to selecting CDMOs.

Read Quality Culture Wins Over Compliance.

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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