Introduction of New Solid Dose Product
The client needed support in Qualifying a new Multi-Product Facilities and Utilities.
Ultimate Solutions was able to provide them with resources on site that lead the Facilities and Utilities qualification and start-up of two (2) new manufacturing areas, including a multi-product area. Our team’s activities as part of the project included participation in quality risk management activities, design activities and the definition of the facilities and utilities requirements for new process and equipment with the Technical Operations and Engineering Automation teams. Additionally, it included the development and implementation of change controls, C&Q documentation, CSV documentation, engineering documentation such as drawings, preventive maintenance, spare parts for the areas. Ultimate Solutions was in charge of Standard Operating Procedures impact assessment, the development and update of new and existing procedures, including evaluation of training requirements, implementation and the area start-up.
The client was able to complete the start-up successfully and on time, deliver to the Operations Department two (2) new facilities including, Air Handling Units, Compressed Air, Potable and USP Water, House Vacuum System and Environmental Monitoring System.
“I learned what goes into the design and qualification of a multi product facility. In addition, this experience show me to work on a larger scale project that involved multidisciplinary departments.”
Author: Amanda Santos, Sr Project Manager