A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems:
Performance Validation (PV) developed and executed the applicable commissioning, installation, operational, and performance qualification deliverables to ensure that all the systems included in our scope were installed and functioned as required by the client and per vendor recommendations. PV was responsible for:
All systems included in PV’s scope were successfully installed, commissioned, and qualified in accordance with the project schedule; allowing the site to meet their projected submission timeline.
The PV Advantage
Performance Validation coordinated with multiple stakeholders to successfully complete all required commissioning and qualification of the systems included in our scope of work. By identifying and incorporating key process requirements associated with each system, PV was able to deliver robust commissioning and qualification packages that fully tested the installation, functional, and quality attributes of each system.
The client has fully commissioned and qualified utilities, chambers, air handling units, and facility management systems serving their new production building supporting a planned capacity increase of 8 million liters per year.
About Performance Validation: Performance Validation is a 100% employee-owned company has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
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VP/ Indiana Division Director
Performance Validation, Inc
Office: (317) 248-8848
Cell: (317) 727-8495