Published on November 18, 2020. View original article on Sharp.
Sharp, part of UDG Healthcare plc, a global leader in contract packaging and clinical supply services, has announced a further investment of $10M in equipment capabilities to directly support client demand in the biologics and injectables market.
QualityOne is a full suite QMS which will be implemented in three phases.
Sharp successfully completed the first phase of QualityOne implementation across its global facilities which now provide enhanced document management, training and electronic change control capability.
Phase two will begin in January 2021, and will provide corrective and preventive action (CAPA) and deviation management. The final stages of QualityOne rollout with Supplier Management will begin in spring of 2021.
The QualityOne project team has been working since early 2020 to provide a standard implementation approach at each facility, along with a FDA 21 CFR Part 11 compliant system.
Barbara Ost, Divisional Vice President for Quality Compliance & Regulatory Affairs at Sharp said:
“QualityOne is the latest development by Sharp to further enhance and strengthen compliance and decision-making while ensuring that we offer a harmonised experience for clients across all of Sharp’s facilities."
“The implementation of the QMS platform is indicative of Sharp’s broader commitment to quality, an area of continuous focus and investment throughout our history."
“We have exceptional quality credentials and a history of strong regulatory compliance. We have also developed programs to certify staff in quality principles and created numerous roles within our organisation dedicated to quality.”
In 2020, Sharp made a number of key appointments to quality leadership roles:
Ost added “These appointments embed a robust and dedicated quality leadership for each of Sharp’s COEs in Allentown PA and a new site lead at our Macungie location.
“Matt Solt will ensure Sharp’s quality philosophy continues to be deployed and maintained at the facility in Macungie, which we acquired in early 2020.
QualityOne is powered by Veeva, which delivers a cloud-based solution tailored to the life sciences, with built-in best practices and automated workflows to give better control and visibility and ensure quality and GxP compliance.
Sharp, part of UDG healthcare, is a global leader in advanced clinical supply chain services and contract pharmaceutical packaging. Offering solutions and support to pharma and biotech clients from phase I trials all the way through to commercialization and rapid launch. The organisation has state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands and over 32 clinical depots globally, covering every region of the world.
Our full complement of integrated services includes: analytical, formulation development, clinical manufacturing & packaging, clinical IRT, blister packaging, bottling, secondary assembly and labelling of injectable presentations, compliance packaging, as well as storage and distribution. Sharp also offers Qualified Person (QP) services for European distribution.
Through our partnership with Berkshire Sterile Manufacturing we also offer specialist isolator-based filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization.
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