Expertise and organisational structure
Designing and building a clean room suite is a complex, high‑risk undertaking that demands robust governance and early multidisciplinary engagement. Getting the right expertise and organisational structure in place early on is essential.
From the outset, a dedicated project board should be established, bringing together internal stakeholders. Success depends on appointing a clean room contractor with demonstrable experience in NHS aseptic facilities. Identification of a competent team to lead and deliver the validation programme from design to operational readiness is crucial.
Setting up a project board
At the beginning of the project, a Project Board (The Board) should be established to oversee and direct the build. The Board defines the project’s goals and ensures alignment with local and wider NHS strategic priorities. It ensures engagement with relevant stakeholder groups, including Pharmacy, Estates, Finance, and clinical teams to encourage joined up thinking and socialisation of the plan.
The Board also provides budget oversight and tracks spending during the project. It has responsibilities for overall project governance and approving key documents like the User Requirement Specification (URS). During the project, the Board will track milestones to ensure timelines are met.
The Board usually comprises Pharmacy leaders, Estates, Finance and clinical experts from the Trust. It may also comprise of advisors on specialist topics such as Good Manufacturing Practice (GMP), Procurement and Safety.
Internal project board members
Roles will include:
- the Chief Pharmacist, who is accountable for the overall success of the project
- a project manager, who is responsible for day-to-day management, timelines, budget, and coordination
- the Pharmacy Aseptic Services lead (Accountable Person or Production Manager)
- the Pharmacy Quality Assurance lead or Head of Quality
- an Estates and Facilities representative who oversees infrastructure, building compliance, and integration with existing hospital systems (Private Finance Initiative (PFI) partner where applicable)
- the Finance lead who ensures budget control, cost tracking, and financial reporting
- a procurement specialist who manages tendering, contracts, and supplier engagement
- a clinical representative (nurses or clinicians) who will use the aseptic products, ensuring the facility supports clinical priorities
For small projects there may be overlap between some roles, for example the Aseptic Services lead may also be the project manager.
External specialist advisors
External specialist advisors are likely to be needed, depending on the scale of the project.
Independent GMP consultants
Several companies have GMP advisers who can provide a high level of expert support based on their extensive experience as MHRA inspectors and Qualified Persons (QPs).
MHRA
If the intention is to operate under an MS licence, or if there will be changes to a currently licensed facility, then early engagement with the MHRA is required. The MHRA Innovations office may be contacted for additional advice if new technologies are planned, or if arrangements may challenge current regulatory expectations.
Architectural consultants
Architectural advice will be required as the project progresses through the Royal Institute of British Architects (RIBA) stages.
The RIBA stages for a clean room build are the same as any other construction project, including:
- strategic definition
- preparation and briefing
- concept design
- spatial coordination
- technical design
- manufacturing and construction
- handover
- use
However, clean room builds require specialised input and detailed documentation in the later stages, particularly from RIBA Stage 3 onwards. This will ensure the specific performance criteria, GMP compliant layouts, process flows and room data sheets are all precisely configured.
The article on design qualification (SPS page) provides more information.
Project management consultants
Professional project management consultancy can be engaged and may be particularly helpful in coordinating large, multi-Trust projects.
Regional Quality Assurance (RQA) specialist pharmacist
The RQA may advise on GMP compliance, validation and quality systems. They may be able to provide further valuable information or resource, such as templates or examples. Under certain circumstances and for larger projects they may join the Board.
Appointing a specialist cleanroom contractor
It is recommended that a specialist clean room contractor is appointed who will bring relevant expertise, and their own experienced subcontractors. Conversely, the appointment of non-specialist architects, building companies, engineering and fit-out firms has resulted in projects experiencing difficulties and delays.
The contracting process will include a detailed URS which forms the key part of the tender documents. The article on writing a User Requirement Specification (SPS page) provides additional guidance.
Individual company responses to the URS require evaluation. Responses will include their:
- ability to achieve the URS requirements, including construction methods
- experience and track record of delivering previous projects successfully
- approach to risk management, including assessment and management of risks of non-delivery
- approach to qualification and aftercare
- construction delivery programme, site management and handover
- arrangements for site Health & Safety
- cost
- approach to all other legal contracting obligations, including social value, equality duties and procurement requirements
Appointing a commissioning and implementation team
A multidisciplinary team will be required to focus specifically on the delivery of the project and the commissioning of the new clean room suite. Its size will vary depending on the scope and complexity of the project. Some individuals will be part of both the Board and the commissioning and implementation team.
This team will report to the Board, and roles and responsibilities within the project should be agreed and documented as the project commences.
The input of individuals will vary through the different stages of the build and qualification of the suite and usually comprises of the:
- Production Manager
- Head of Quality Assurance
- Accountable Person (if Section 10 unit)
- Chief Pharmacist
- Finance and contracting team representatives
- Estates representatives
- subject matter experts for fire, electrical, Heating, Ventilation and Air Conditioning (HVAC), building regulations
- third party GMP advisors or validation specialists
- Regional QA advisors
Once the specialist contractor is appointed, the commissioning and implementation team will also include the:
- Principal Designer
- contractor’s Project Manager or Site Manager
- key sub-contractors if applicable
This team may also include an architectural lead, supply chain manager, structural engineers or other specialists identified by the Board.
Further details about the responsibilities of the commissioning and implementation team throughout the building and commissioning stages can be found in the other articles in this series.