The challenge:
Expand production & maintain production timelines. Expand production & maintain production timelines.
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A top Fortune 500 healthcare company wanted to increase the production to meet worldwide demand. They lacked the internal team and capabilities in-house to rapidly build, install, and qualify the equipment needed to expand.
The company required specialized talent with manufacturing qualification experience who could ensure the latest Food and Drug Administration and the Medicines and Healthcare Products Regulatory Agency requirements were met. It also needed to navigate the impact of the 2020 COVID-19 pandemic and aspects of Brexit to safeguard production timelines
The solution:
Targeting drug manufacturing support.
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The Vita Global Sciences (VGS) team designed a tailored solution for the client focused on manufacturing qualification. The team sourced unique SMEs and partnered with a local Good Manufacturing Practice (GMP) company for access to their GMP SMEs with pharmaceutical equipment qualification experience. The VGS team took full responsibility for the deliverables for the production qualification project including governance, capacity management, daily activities, and the facilitation of additional resources. This VGS Functional Service Provider (FSP) solution is designed to support the lifecycle of the drug development process, including discovery, preclinical studies, clinical trials, FDA review, scaling of manufacturing, go-to-market strategies, and post-market surveillance.
The value:
Capacity expanded, budget managed, & quality maintained
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VGS had a local qualification team ready within two weeks and managed to avoid delays. VGS’ FSP solution allowed the company to continue clinical development in-house, which was executed to its standards, utilizing its systems and KPIs, but without using its staff. This ensured that deliverables were met on time and manufacturing qualifications were maintained. VGS provided a team of ten experts that included a project manager, a project coordinator, a senior validation engineer, two validation engineers, a computer system validation engineer, two quality assurance specialists, and a qualified pilot & technical SME.
