Project: Clinical Supply Packaging Unit

Location: Belgium

Validation Consultants

A research client in Belgium appointed The GMP Group to write the concept design and carryout all validation operations for a refurbishment and extension of the Clinical Supply packaging Unit (CLPU). The client developed with The GMP Group the conceptdesign based on the validation being the project tool for the completion of the facility and the new equipment. At no stage during the project design, construction, or procurement of equipment does the validation not form part of the overall thinking and the life cycle model for validation is used in all cases.

Feedback from the concept design, detailed design, construction and installation is available as the qualification protocols are developed and approved in parallel to each of the other tasks.
The GMP Group are responsible for developing the URS and FS for all equipment procurement and in ensuring that all factory acceptance test protocols are developed to support documentation as detailed in the URS and developed in the FS is the responsibility of The GMP Group Ltd.