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What You Don’t Know Can Hurt You

What You Don’t Know Can Hurt You

As any experienced project manager can attest, the undocumented aspects of legacy facility renovations represent a very real risk to the project. One can never eliminate 100% of the risk, but early planning at critical junctures can help mitigate the downside. Before committing to a building acquisition for GMP manufacturing, we advise conducting an engineering assessment to determine the property’s suitability for the planned operations. Site services should be evaluated against the anticipated utility demands of the process. The general condition of the building should be assessed, and the structural support capacity should be understood in the context of anticipated equipment loads. Beyond that, some selective demolition and foundation testing may be helpful to see what you are up against.

The design process for renovations typically starts with a field survey
to document existing conditions at the site.

Even when “as-built” design drawings are available, it’s a good idea to verify the accuracy of these drawings during the site survey. At this stage, it’s essential to bridge any deficiencies in the documentation– missing drawings, incomplete or inaccurate documentation, and any undocumented obstructions in the renovation area.

It’s Complicated
Beyond legacy facility unknowns, the next highest renovation risk identified by GMP manufacturers was upgrading equipment to address obsolescence or cGMP gaps. Suppliers (mostly engineering consultants) ranked this one lower – perhaps because this is an issue that is frequently addressed directly by the owner and equipment vendor. Here’s the issue: The documentation typically provided with proprietary equipment is not intended to support future equipment modifications, and many equipment vendors may not provide custom modifications of legacy equipment.  As a result, new equipment may be required if the original equipment cannot be modified. If the equipment in question is part of a validated manufacturing process, then it becomes even more complicated.

The feasibility of equipment modifications is best addressed
separately before you tackle a facility renovation.

Design to Comply
The remaining risk categories touch on requirements that are integral to current Good Manufacturing Practice. These include:

  • Impact of renovation on facility segregation and flows
  • Process validation and/or regulatory issues
  • Construction activities adjacent to GMP operations

The impact of renovation on facility segregation and flows is a legitimate concern, since adding onto or repurposing space often disrupts the orderly movement of people, materials, equipment, product, and waste through the facility.

Facility programming may require rethinking the movement of people and materials
for legacy manufacturing within the facility, as well.

It’s no surprise that Process validation and/or regulatory issues also ranked highly, since the central mission of a cGMP project is to ensure that manufacturing operations can produce a compliant product. One of the unique aspects of working in GMP space is that the impact of validation – on cost and schedule – is a significant consideration in the development of the project scope, and may place additional constraints on the project.

Finally, most of the renovation projects we engage in at DME involve construction adjacent to ongoing cGMP operations. Minimizing disruption to these operations is always a project mandate.

It is essential that any atypical activities within the facility
are properly segregated to prevent product contamination.

Fortunately, this is a risk that can be mitigated through careful planning. We typically work closely with the owner, building contractors and construction manager to develop a detailed plan for segregating manufacturing space and utilities in operation, and for managing the separate and safe movement of people, equipment and materials to and from the construction zone. In addition, a phased construction strategy may be required to facilitate an orderly transition to cGMP manufacturing with minimal disruption to adjacent operations.

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