However, while the pharma sector has seen new efficiencies and an increased pace in development, the time requirements for building new facilities to produce these novel therapies have not kept pace. They still need budgets, designs, permits, land, construction, and regulatory approval. The entire process can take between 12 and 18 months or longer for large-scale or more complex projects. There are several steps that companies can use to save time and money on these projects and having clear and reasonable benchmarks is essential.
Pre-planning
One of the first steps for any project is finding suitable land for development. A company may already own the land or may need to purchase a parcel. In some cases, a company may choose to renovate an existing structure to house new production equipment or lease an existing warehouse-type building to house the production facility to increase the speed of completion. Regardless of the development method, it will be necessary to obtain real estate entitlements to ensure that the local government will allow construction. The project could entail several entitlements that include land use permits, zoning, and approval from the local utilities. Depending on the zoning laws, developers may need to petition the local planning board to either rezone the land or issue a variance to allow the project to go forward.
Internal financial approvals will go a lot faster if benchmarking information is employed to build budgets and schedules for projects. In addition to that, the company will have historical data on all similar facilities, which will help establish an accurate cost and timeline for the project.
Another thing to consider at this stage is adaptive manufacturing inside the facility. This requires the company to design Standard Operating Procedures (SOPs) that give it the flexibility to produce more than one product. For example, the company could use new technologies and techniques within the facility to make new products while retaining its protocols. These SOPs are submitted to regulators like the Food and Drug Administration (FDA) for approval. Getting the regulator's endorsement early can allow a more agile manufacturing experience down the line, should changes become necessary. During the pre-planning stages, the design will allow for adaptive manufacturing already placed within the regulatory approvals.
Designed Right the First Time
Once the land or building site has been secured, the next step is setting a budget and starting the design process. Best practices say that the design will take from six to nine weeks for each stage, and it is recommended that a third-party estimator works with the designer to ensure that the plans will stay on budget. There is no point in doing the design work on a project that will cost $300 million when the budget is only $250 million.
While it might seem counterintuitive, the process of negotiating and purchasing the manufacturing equipment to be used inside the new facility should begin during the design phase. Currently, there are supply chain issues for a significant number of products around the world due to COVID. Placing an order well in advance of when they will be installed can eliminate concerns about whether the equipment will be available when required to avoid costly construction delays. Many healthcare centers use this system when building new facilities to great effect.
Permit Problems
Obtaining building permits can cause a developmental bottleneck. Depending on the jurisdiction and complexity of the build, this process can take up to eight weeks or more. Little can be done to expedite the process, but it allows project managers to plan then begin construction once the permits have been approved. This is the ideal time to start hiring contractors, securing heavy equipment, and ordering construction materials. Also, planning multiple phased permitting processes will allow the projects to break ground early, install steel, receive a civil and structural temporary certificate of occupancy (TCO), and a manufacturing facility TCO's in advance of remaining areas.
Construction on Time and Budget
Once permits are issued, the real work begins. This is the most time-consuming portion of the project, one that lasts at least a year. It is also the phase where minor delays can push timelines into more significant and expensive problems. However, there are ways to cut construction time without reducing quality, and they revolve around solid pre-planning and having an integrated schedule.
One typical delay for large projects is that materials are not ready on-site when they are required. For example, labor on the building's foundation can be completed, but work grinds to a halt because the steel for the frame is still being designed or manufactured. With an integrated schedule, these gaps can be identified and filled to minimize or eliminate downtime.
Many people outside the construction industry think adding more workers will speed the project up. However, having more than one worker per 400 square feet is not conducive to an efficient environment. Once the staggering and flow of activities get out of order, on-site labor will only get in each other’s way and can slow progress down more than speed it up. Another solution is adding a second or third shift, but again, there can be timing issues. There is a sequence of events that construction follows because not all trades work at the same pace. For example, installing plumbing and electrical systems is a time-consuming process. It cannot be started until the carpenters have roughed in the structure, while drywallers and painters cannot begin until the plumbers and electricians have finished. But through workflow pull planning, all trades can have enough time to complete their work and not be idle. For example, pull planning sessions allow the foreman on-site to be accountable and size their crews correctly to achieve activities in a timely manner.
Another technique that has become popular for these complicated builds is the use of prefabricated pods, modular cleanrooms. For example, a cleanroom is built at another facility and transported in pieces to the building site. It can be assembled, tested, and installed into the building at the appropriate time, or stored nearby if there are delays; this method is significantly faster than building one from scratch. Many construction projects use prefabricated or modular components for elements like stairs, elevators, walls, and roofs.
Approvals for Operation
Once construction on a pharmaceutical manufacturing facility is complete, the next step is obtaining approvals from regulators and the validation process. This can take six to eight weeks depending on the complexity of the facility and requires a physical inspection. The risk-based qualification allows the timeline to be incorporated into the project schedule by completing the technical portions of the building (i.e., the cleanrooms, labs, and manufacturing areas) first. The validation process can be achieved simultaneously with cleanroom /manufacturing areas while construction continues on more minor essential spaces like offices, washrooms, and cafeterias. That way, they have the necessary approvals around the time construction is completed, and the facility can start making the product as quickly as possible.
Designing and building a new facility takes at least a year, depending on the size and complexity of the project. But having experienced professionals that employ benchmarks, integrated schedules and other techniques, can not only cut waste and inefficiencies but can trim as much as two months from a project. When a project needs to be completed quickly, this experience can be worth its weight in gold.
