Colchester Hospital University NHS Foundation Trust identified a need to increase its capability to manufacture chemotherapeutic preparations. A new facility was envisaged aimed at meeting the needs of an increasing number of patients, and fully compliant for licencing, in line with MHRA Good Manufacturing Practice (GMP) requirements.
Our role
CCTech worked with Colchester Hospital University NHS Foundation Trust to develop and implement a process whereby the new facility met the MHRA regulatory requirements:
- Development of a detailed User Requirements Specification (URS) to ensure that all aspects of the process, as understood and practiced by the users, were faithfully reproduced in the design and operation of the facility.
- We developed the validation process to ensure that the facility achieved compliance under MHRA GMP requirements.
- CCTech worked with the design team to advise on how to ensure compliance with GMP. We ran workshops to ensure the design met with user requirements and addressed any inconsistencies or concerns from the client.