Facility Design Review
The design and build of a new GMP manufacturing facility is often a complex and time-consuming process that typically includes a substantial cross-functional team from multiple companies and organizational departments. The team members usually dedicate large amounts of their working time to ensure a robust facility design that meets user requirements and regulatory agency expectations for GMP manufacturing. Often, due to the time and workload requirements, organizational departments may need additional resources to act as representatives or liaisons during the design and construction process.
Sometimes companies may not have the necessary design expertise on staff to expand from an R&D or clinical facility, to commercial manufacturing. We can provide GMP experts to help establish, and facilitate the GMP manufacturing requirements and compliance expectations into the facility design, and troubleshoot compliance issues arising during construction.
We have the expertise to provide an independent review of your facility design. Sometimes multiple small adjustments to facility design together result in a large change that may affect GMP compliance. We can provide independent GMP experts to a take a fresh look at your facility design, prior to finalization, to confirm or question design decisions that may have arisen through multiple rounds of design modification.
An example of a GMP manufacturing facility design review may include the following:
Cleanroom Finishes and Materials of Construction,
Cleanroom Classification Requirements,
Cleanroom Differential Pressure and Cascading Requirements,
Biosafety Level (BSL) Requirements,
Multi-Product Facility Segregation and Cross-Contamination Prevention,
Room Layout with Respect to Personnel Flow and Gowning Requirements,
Equipment and Material Flow in the Facility,
Product and Sample Flow in the Facility,
Location and Use of Airlocks and Pass-Throughs,
Hazardous Waste Decontamination and Removal Requirements,
Tie-in to Existing Manufacturing Space and GMP Utilities,
Design to Allow Future Expansion Access.