Any Time, Any Place, Any Product: A Roadmap for Successful International Pharmaceutical Plant Construction Projects

Procurement and shipping/trafficking are major concerns for projects sited in remote locations. Suppliers must be experienced in overseas shipment, customs and excise taxes, and local routing in the site location. In some cases, tax benefits for process and support equipment can be impacted by the choice of the supplier. In addition, proper marking and tagging of freight entering a country is necessary to preserve tax savings offered to the Owner. An improperly marked crate or container can be held up for weeks in customs, or can cause the project to incur unnecessary costs for taxes and fees.

Every country has unique requirements for the entry of equipment and systems, so supplier prequalification and preplanning is essential for successful procurement. If a preferred supplier does not have proven experience in shipments to international locales, the owner should contract a freight forwarding consultant to advise in the process. Large pieces of equipment and modular systems will present significant challenges for the project, and in many cases, the transports (trucks, low-boy trailers, dollies, etc) must be imported along with the equipment.

It’s a good idea to establish agreements with local suppliers shortly after mobilizing on the site. Many bulk material items, such as structural steel, siding and concrete panels, and non-hygienic piping, may be sourced locally. The facility will rely heavily on its area suppliers after completion, so establish these relationships during construction.

5. Construction: Bringing it all together

Thirty years ago, contractors from the United States and Europe would simply “airlift” all necessary resources to the site, complete with the associated costs for labor camps, expatriate subsistence and travel. Today, the expertise of construction craft personnel aro und the world has increased dramatically, to a point where it is hard to justify many expatriates for construction of an international project.

However, there are certain functions of the construction process that must be evaluated during the initial planning phase to ensure that the construction approach is sound. Management in the field should never be compromised. Close attention must be paid to:

• Safety — Owners may be surprised to find that safety programs that are taken for granted in developed countries don’t exist in many locations abroad, so the owner and contractor must establish a rigorous and effective safety program. Procedures should be developed to fit local culture and customs, but the ultimate goal is to establish a “project culture” that ensures worker safety and environmental protection.
  
  
• Transfer of design intent — Initial planning for the project should consider the means by which the design intent will be transferred to the site. Once the design has gotten “cold” in the field, it is occasionally difficult to reconstruct the decision process that led to a specific design feature. Sound international projects always include a methodology for ensuring that the construction site staff has the benefit of the project technical approach established during the conceptual phase and formalized during detailed design.
  
  
• Contractor capability — Knowledge of the local business environment and the capability of area contractors is critical for execution in an international locale. In every instance, contractors should be prequalified prior to bidding to verify the number of available craft resources, ensure that proper management staff and procedures exist, and determine the past safety performance.
  
  
• Local customs — The construction manager must be aware of the social, legal and attitudinal differences between his or her home region and the site location. Language and religious customs are the first differences that surface and must be accommodated.
  
  In addition, the site staff must be keenly aware of the holidays and work schedules that are expected by the local work force. In several Asian countries, for instance, workforces can shrink dramatically during the rice harvest season, and the schedule can be impacted if this period was not anticipated. Overtime is commonly used as a schedule acceleration tool, but in many locations the workforce traditionally works a set weekly schedule with little or no variance.
  
  It pays to hire an assistant project manager to serve as a translator and guide to local customs, keeping in mind that indigenous people always appreciate foreign nationals who at least try to learn their language.
  
  
• Ethics and legal complications — Bribery or under-the-table payments are still common in some areas of the world. Principled managers must avoid even the appearance of wrongdoing to protect the fiduciary interests of their companies and the owner.
  
  
• Differences in construction tools and methods — A construction manager with limited international experience may be shocked to see some of the work practices in developing countries; for example, labor jurisdictional lines may be enforced in some countries, while, in others, these trade distinctions may not exist. In either case, the construction manager and the engineer must be aware of the approach that the local trades take to their work, so that the construction documents can match the local means and methods.
  
  
• Productivity assessment — “If it’s not measured, it’s not managed.” The only means to ensure that the project is tracking to its budget and schedule targets is to constantly measure and track the results of construction activities.

6. Facility Qualification: If it won’t pass, it won’t pay off

Once a pharmaceutical facility has reached mechanical completion, a great deal of effort remains before it reaches its ultimate purpose. Not surprisingly, the key to a successful commissioning and validation phase is set early in the project, when the management team completed the project schedule.

The start-up sequence of systems should be part of the construction completion plan, with the system turnover addressed as a logical cascade of activities instead of a vertical wall of system completions. Most systems in the cascade should be turned over by construction prior to mechanical completion with a few process and HVAC systems at the end.

Some of the more challenging aspects of commissioning and validating an international project include finding qualified staff, determining start-up consumables and spare parts, and ensuring compliance with international regulations. A compliance master plan defines the guidelines to be met, and this living document serves as a road map for compliance, revised as necessary throughout the life of the facility.

By selecting experienced engineering and construction partners for an international project, the owner has taken the first step towards delivering a functional and compliant facility. Much of the project execution process is applying basic risk management and following the best practices established in the past, regardless of project location. However, each project has its unique challenges, which are overcome by understanding the similarities, and more importantly, the contrasts from previous projects.

In the global environment, each new location presents logistical problems, resource issues, and hardships that potentially have not been addressed in the construction of past pharmaceutical projects. However, if the project team thoroughly considers the location-specific aspects of the work, and is constantly aware of the cultural implications, no location is beyond the reach of the industry.

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About the Author

Harold Boman serves as vice president of operations for Fluor’s Life Sciences business. He is responsible for project operations including sales support, contract negotiation, project execution, and client relations, as well as direct supervision of regional and functional managers in six countries. His 30 years of industry experience includes project engineering and construction management for biotechnology, pharmaceutical, manufacturing, oil & gas, and modular facilities. Boman holds a mechanical engineering degree from the Georgia Institute of Technology, Atlanta.  He can be reached at Harold.boman@fluor.com.