Consultancy Services relating to the design, validation and Qualification of Clean Rooms within Gene Therapy Innovation Manufacturing Centre

Services are required for a number of tasks during the Qualification and Validation stages of the build completion of the Research and Development facilities including all Quality Control, Clean Room areas in grades C and grade D environments in addition to all process areas across the site and supporting site operations such as major infrastructure and support services such as logistics in addition to other areas.

These works are to cover the following areas / requirements:

Qualification Requirement Matrix prepared to track Validation Lifecycle and to support;

MHRA Audit. Used on previous MHRA audits and proved effective;

Validation Assessment, User Requirement Specifications, Validation Plan, Design Document Reviews;

Vendor Document Reviews, Factory Acceptance Tests Site Acceptance Tests (Commissioning);

COTS Installation/Operational Qualification Protocol, Installation Qualification Protocol;

Thermal Mapping Protocol (Empty and Loaded), Operational Qualification Protocol;

Performance Qualification Protocol, Validation Summary Reports;

It is envisaged that the majority of documentation preparation will be carried out remotely from the new build site, however, close working relationships will be required with attendance at site meetings for all aspects of the build and clean room fit outs will be required therefore an estimate of 50% site attendance is anticipated.

It will be a requirement that the provider will regularly visit site throughout the construction period to ensure that the build is being documented to a suitable standard to allow for information leveraging into qualification. These visits will also be to ensure that the MHRA are suitably informed throughout all stages of the construction period.

Attendance by the provider and being that professional capacity for all engagement with the MHRA will be a major requirement and throughout the Licence application process and to assist the client in this application process through to successfully licence being granted.

Major recent experience is therefore a pre-request in interaction with the MHRA in the field of both Cell and Gene Therapy, Clean Room Manufacturing, Covid-19 Vaccine Response and recent demonstrated deployment / experience within Cell and Gene Therapy is of the highest importance.

As part of the process of validation and qualification, down stream training will be required to be delivered to allow for periodic validation of clean rooms areas by incumbent UoS GTIMC and UoS Estates and Facilities staff.

The project has extremely aggressive timelines with build construction due for completion in July 2022 and therefore standing up of this service will be required to be in place during the early stages of February 2022.