The Supply & Installation of a Quality Management System

Cell & Gene Therapy Catapult (CGTC) is part of a world leading network of technology and innovation centres looking at bridging the gap between businesses, academia, research and government.

The long term Government investment being made, is to transform the UK’s ability to create new products and services within the cell and Gene Therapy arena, opening up global opportunities for the UK and generate sustained economic growth for the future.

The current CGT facilities based on the 12th Floor of Guys St Thomas Hospital in London hosts around 130 personnel with laboratories covering a square metre space 1,200m.

CGTC is currently building a £55M large scale advanced therapy medicinal product (ATMP) manufacturing centre (CGTMC) at Stevenage Biocatalyst in Hertfordshire.

The CGTMC is planned to open in May 2017 and will be operated as a multi-occupier (collaborator) facility for UK and global companies that are looking to scale-up the manufacture ATMPs for Phase III studies.

CGTG are currently looking to engage with potential system suppliers with a suitable electronic Quality Management Solution to implement into the Manufacturing Centre pre May 2017.

The QMS solution modules will include document control (end-to-end GMP lifecycle management), Deviation Management, CAPA, Audit Management, Training and Compliance, Change Control, workflow functionality along with associated supporting API interfaces and the capability to accommodate the addition of other user configured workflows at a later date.

Cell & Gene Therapy Catapult would like to engage the supply market at this early stage to understand and interpret market intelligence into our decision making process.

As such, this PIN does not formally signify the beginning of any procurement and does not constitute a commitment by CGT to undertake any procurement exercise.

Your comments are invited on all questions raised in the attached document.