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Article / Dec 26, 2025

Recurring GMP Maintenance Errors Identified by Hovione VP David Basile in Pharmaceutical Manufacturing

Gene Online, 26 December 2025

David Basile, Vice President of Technical Operations for the Americas at Hovione, has identified several recurring errors made by pharmaceutical companies in the maintenance of manufacturing facilities and equipment. These missteps occur within the framework of Good Manufacturing Practices (GMP), which are critical for ensuring product quality and compliance with regulatory standards.

Basile points to a range of issues that commonly arise, including inadequate preventive maintenance programs, improper documentation practices, and insufficient training for personnel responsible for equipment upkeep. He also highlights challenges related to aging infrastructure and the failure to implement modern technologies that could improve efficiency and reliability. These shortcomings can lead to operational disruptions, increased costs, and potential regulatory non-compliance. The observations underline the importance of robust maintenance strategies in maintaining high standards within pharmaceutical manufacturing environments.

Read the full article at Geneonline.com

 

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Hovione is bringing momentum to the intranasal field after announcing that its lead single-use nasal dry powder device, developed in collaboration with Industrial Design Consultancy Ltd (IDC), is now available for commercial partnerships. The milestone marks the transition from prototype to a fully integrated intranasal drug delivery platform that spans Hovione’s end-to-end partnership capabilities–from API synthesis through advanced formulation and particle engineering to drug product manufacturing, including device supply and advanced analytical tools for nasal performance characterization. The platform’s single-use device is designed to be manufacturable at scale and to leverage existing advanced particle engineering and drug product manufacturing capabilities, a practical advantage that can shorten timelines to clinic and commercialization while reducing development risk and cost. The device’s patented mechanism supports targeted nasal deposition, including access to the upper olfactory region. This enables rapid systemic absorption and potential nose-to-brain delivery pathways that are increasingly important for CNS and emergency-use indications. Beyond the single-use format, Hovione and IDC are advancing a multi-dose variant to broaden applicability across dosing regimens and therapeutic areas. The collaboration is backed by an intellectual property portfolio and initial patent grants, positioning the platform as a turnkey option for pharma partners seeking a single integrated supplier for both drug substance and device. This development arrives as intranasal delivery gains traction for systemic, CNS and rapid-onset therapies. This is precisely the focus of the upcoming 4th Nasal Formulation & Delivery Summit, for which Hovione is a key sponsor. The annual summit unites formulation, delivery and product development leaders to tackle drug-device compatibility, translational preclinical models, and strategies for scalable, regulatory-ready intranasal programs. Hovione’s recent progress will be highly relevant to attendees looking to de-risk nose-to-brain and systemic intranasal programs. Read the full article at News-Medical.net    

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