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Medical Manufacturing
Facilities and Utilities Commissioning and Qualification
Equipment Process Method Cleaning and Computer Systems Validation
Packaging
Project Management
Validation
Environmental Monitoring and Sterilization
Due to a facility expansion, a global pharmaceutical manufacturer needed to engage with an organization that could provide Commissioning, Qualification and Validation services. The 90,000 square feet facility expansion included three new filling lines of blister and bottle filling operations. Limited in-house expertise and time sensitivity related to the expansion schedule led the organization to seek professional services, as well as project governance, to address the scope and to confirm all the commissioning, qualification and validation services were performed for the expansion.
We provided a team of Commissioning, Qualification and Validation engineers along with a Project Manager with expertise in the following areas: Cleaning, Equipment, Process, Packaging, Sterilization and Facilities/Utilities Engineering. Our Project Manager, working in conjunction with the client management team, wrote the Master Validation Plan for the site expansion and provided oversight of the resources performing the work. Sound engineering, scientific and risk-based principles were used by our team to demonstrate how we successfully delivered facilities equipment and processes that were fit for use and functioned as intended.
By leveraging our ‘Build-to-Fit’ approach, we were able to minimize project costs while rapidly deploying the resources needed to stay within the tight timelines needed for the expansion. The project governance provided helped our team to successfully deliver on time and within budget fully validated facility, equipment and processes. Our team’s success allowed the client to sustain high quality production within a consistently performing operations environment.