By John Godshalk, Principal Consultant, JGBioConsult
Building a GMP Facility and fitting it with the proper equipment for your product can be tricky and time consuming. It is often difficult to right-size a facility for clinical trial phase products when you don’t know what the future holds, both for number of products/INDs and throughput/number of lots needed. Even with good planning, building a facility one or two years in advance of the need can be challenging in terms of both funding and putting the right design team together. One aspect I want to talk about today is the concept of “right sizing” and if that is possible.
I sometimes see GMP facilities that are too small for the current number of products or throughput/number of lots being produced. No one wants to have unused space they are paying rent for, but this might actually be the best approach for future-proofing GMP facilities. I rarely see facilities that are too large—with lots of build-out space left. More often, I see GMP spaces that are right-sized (the best scenario) or ones that are at their full capacity, and cannot support another product.
Remember that having adequate space for GMP operations is a GMP regulatory requirement. For US GMPs, this is in 21CFR 211.42 “(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. (b) Any such building shall have adequate space for the orderly placement of equipment and materials…” Of course, biologics like cell/gene therapies are also drugs under the law, so the drug GMPs (quoted here) apply.
But what is “adequate space” and how do you know if you have adequate space? One hint is if everything is packed in and there is no more room for anything. I have seen GMP production facilities that looked like NYC apartments—with stuff stacked floor to ceiling. I’ve also seen GMP facilities that are packed, with no room for even one more person or piece of equipment. These are strong hints that there is not enough space for operations, and therefore, a higher risk that other GMP infractions could occur, such as those for keeping things separated and preventing mixups.
Having adequate space requires good planning and good resources for GMP Facilities. Planning with at least a 2-year horizon is often needed, to plan for new products and new INDs. It usually takes a year to build a facility, and up to a year to outfit it with equipment and complete validation work. It is also quite expensive to build a GMP facility, whether from an existing building or a brand new one. Both good planning and resources are needed.
I often get involved with GMP Facility planning and design. Working with architects and the design team, I help with interpretation of GMP regulations and requirements as they relate to good GMP facility design principles. An important aspect of this work is to ensure that the new facility has adequate space for both current and future operations.