Facility Renovation for New API

The Challenge

A leading manufacturer of over-the-counter store brand pharmaceutical products underwent a facility renovation for a new product line.  In order to safely manufacture and regulate the new active pharmaceutical ingredient (API), a reconfiguration of utilities including HVAC, dust collection, purified water, compressed air, and nitrogen was required.

The Solution

Performance Validation’s experience with this client site and initial facility expansion projects allowed the team to hit the ground running considering the demanding project timelines.  The Performance Validation team was responsible for validation project planning, development, and execution of equipment qualification protocols and functional tests of the reconfigured systems.

PV worked with the client to define the project scope and understand the criticality of the renovation in order to meet quality and safety standards.  Once engineering documentation requirements were determined, the PV team developed the protocols to perform installation qualification, operational qualification, and performance qualification activities.  Project execution required coordination with several groups including construction, automation, technicians, and project engineers.

Daily team meetings were held to monitor progress and address any issues that could potentially compromise the deadline.  PV was actively involved with troubleshooting and assisted with corrective actions to ensure all results were in specification and compliant.

The PV Site Lead maintained a project priority list and managed the schedule, status, and budget of each project from start to finish.

The Results

All projects associated with the facility renovation were completed according to schedule allowing R&D to commence their trials in the new suites.  PV exceeded the client’s expectations considering the vast workload and extremely limited timeframe.  Team members exhibited ambitious attitudes, excellent communication skills, and showed dedication by working extended hours in order to successfully complete all validation efforts.

 

For additional information please contact:

John Underwood
Michigan Division Director
5168 Sprinkle Road
Portage, MI 49002
Office – (269) 393-9112 X 2752
Cell – (269) 217-035