Essential questions to ask before embarking on a pharmaceutical fit out project.

Pharmaceutical fit outs require the utmost level of planning and execution to ensure the levels of quality and safety this specialised industry demands. Given the right preparation and planning, and by asking the right questions in the planning phase, processes can be streamlined, workflow can be improved, and more inspirational spaces for research, development, and production can be created.

So what are your specific objectives for this fit out?

Before embarking on your pharmaceutical fit out journey, the ADCO team helps you consider factors such as the size of your facility, the type of pharmaceutical operations you will be conducting, and the number of staff members who will be working in this space. Additionally, we will work with you in thinking about the specific needs of your operations. Do you require specialised areas such as cleanrooms or sterile environments? Will you need dedicated spaces for research and development, production, and quality control? This exploration process will help you determine the scope of the fit out project and ensure that it aligns with your long-term goals.

By identifying your requirements and objectives upfront, you can collaborate with your fit out company and ensure that the final result meets your unique needs. 

What compliance and regulatory requirements are there?

“When you go into a pharmaceutical environment, the list is endless with the amount of controls you need to be thinking about all of the time. The regulatory protocols and procedures are far more stringent than just working in a live office building.”

Mairead Luttrell, Pharma Division Manager

Compliance with regulatory standards specific to your operations includes understanding the guidelines set forth by regulatory bodies such as the FDA (Food and Drug Administration) or EMA (European Medicines Agency).

You may also want to target sustainable building benchmarks and accreditations such as LEED or BREEAM. Your fit out contractor will have the experience of working with pharmaceutical facilities and the applicable regulations. They will guide you through the process of meeting compliance requirements, including the design of cleanrooms, HVAC systems, and other critical components. Failing to comply with regulatory standards can result in severe consequences, all the way from heavy fines to reputational damage.

What is your budget and timeline?

Setting a realistic budget and timeline with the commercial and project management team at ADCO determines how much you are willing to invest in the fit out and allocate funds for design, construction, equipment, and any unforeseen expenses. Ongoing operational costs over the lifecycle of the building have to be considered, such as maintenance and utilities for instance.

A realistic timeline will take into account the complexity of the fit  out, regulatory approvals, and any potential delays. Your fit out contractor will get a clear understanding of the expected duration of each phase of the project. It is important to balance efficiency and speed with quality and attention to detail. The temptation to rush the process can lead to costly mistakes, waste and programme creep.

What technology and equipment will you need?

Collaborating with a specialist pharmaceutical contractor such as ADCO will ensure that your facility is designed to accommodate the advanced technology and specialised equipment essential to your operation. When it comes to development equipment, manufacturing machinery, analytical instruments, and storage systems, factors such as power supply, ventilation, and space requirements need to be considered. 

What environmental considerations are there?

Now, more than ever, the effects and impacts of your pharmaceutical fit out will be under the environmental microscope. Sustainable practices have to be implemented into your fit out process to minimise those impacts. 

At ADCO, we work closely with you to identify sustainable design options and materials, incorporating renewable energy sources such photovoltaic panels and utilising locally sourced building materials where possible. By prioritising environmental considerations, you can reduce your operation’s carbon footprint and contribute to a more sustainable future. You can also read more on the benefits of green buildings for the pharmaceutical sector. 

What contingency plans and risk management strategies do you have in place?

Even with meticulous planning, unforeseen circumstances can arise during a fit out project. Consider factors such as availability of labour, materials, or delays arising from long-lead items. Staying proactive and prepared will help to minimise downtime and ensure a seamless transition into your new pharmaceutical facility.

At ADCO, we identify potential risks, develop emergency response plans, and maintain open lines of communication with our clients. Effective communication is critical on pharma fit outs. It promotes safety, cost-effectiveness, and collaboration, all of which are essential for successful project outcomes.

Are you speaking to the right pharma fit out contractor?

A successful pharmaceutical fit out requires the expertise of professionals and consultants who specialise in this field. Engaging the right team will ensure that every aspect of your fit out is planned and executed with great attention to detail. So you should only consider working with an experienced fit out company that has a proven track record in designing and constructing pharmaceutical facilities.

Mairead Luttrell, Pharma Division Manager at ADCO, has over 10 years of experience in Ireland and internationally in pharmaceutical and medical environments. She has managed projects for clients such as MSD, Alexion, Pfizer, Allergan, and Amgen. Her project experience includes new builds, design and build, fit out, refurbishment, cleanrooms and shutdowns. Mairead is responsible for the full remit of ADCO’s pharma division including contract negotiation, cost and waste minimisation, client management, stakeholder engagement and resource management.

If you’d like further information on what it’s like to embark on a pharmaceutical fit out journey with ADCO, you can download our Pharmaceutical Fit out & Construction Experience Brochure. Or you can learn more about some of the pharma projects we have completed here. Of course, you can always reach out to Mairead, who will be only too happy to answer any of the questions listed above.