Main Contractor: Strood's
Contract Value: Circa £10m
Due to predicted increases in demand, the Trust had identified a need to increase the size of its existing capability to manufacture chemotherapeutic preparations from an existing two isolator boxes to four isolators.
The new facility will serve the needs of increasing numbers of patients and retain compliance under GMP for licencing with the MHRA.
CCTech worked with Colchester to develop and implement a process to ensure that the delivered facility met with MHRA regulatory requirements:
• A detailed User Requirements Specification was developed
to ensure that all aspects of the process were represented
in the design and operation of the facility.
• We developed the validation process to ensure that the
facility will achieve compliance under GMP, a prerequisite
for licencing with the MHRA. The validation process forms
an integral part of the construction programme.
• CCTech worked with the design team to advise on
compliance with GMP. We ran workshops to ensure the
design met with user requirements and addressed any
inconsistencies or concerns with the client.
• CCTech deliver and manage the validation process including
the Validation Master Plan consisting of Scope, Process
Details, Validation Strategy, Acceptance Criteria Guidelines,
Validation Programme, Document Format and Control,
Change Control and Re-validation Policy and the
• Soft Landings. CCTech proposed to develop and manage this
process in line with Government Soft Landings policy to
develop a full building aftercare process, ensuring that the
facility continues to meet its designed capability after
The project has been tendered and is expected to commence construction in April 2019.