Many biotech firms contact the FDA when their facilities are in the design stage even though the FDA does not require a pre-construction review. If the company desires, FDA personnel will "walk through" proposed floor plans and systems. The FDA will generally spend less time reviewing the establishment application if it has previewed a facility design.

It is critical to think about validating facilities and systems during the planning stage. Once construction is completed on a biotechnology facility, make sure it is operating in compliance with Good Manufacturing Practices before the investigator from the Food & Drug Administration comes out to look at it.

Concurrent validation makes good business sense. It is a way of validating the people as well as the process. During the inspection of facilities for approval of a drug product, the FDA investigators will ask to see written procedures, test methods, specifications, sampling plans and test results to see if the operation is in compliance with GMPs. At the conclusion of the inspection, they will discuss their findings with the facility manager. This is where to ask questions. Ask them to clearly articulate the problems, then determine a strategy for correcting the problems as quickly as possible.

Biotech products are particularly sensitive to microorganism contamination, and temperature levels of 2°C to 10°C may be necessary to prevent contamination. Temperature control of heat-sensitive biological products is frequently insufficient in biotech manufacturing facilities. Temperature controls must be taken into consideration at all levels including production, purification, formulation, filling, packaging and storage.

A manufacturing process that works successfully in a pilot plant may be difficult to size up to large-scale manufacturing for commercial distribution. You have to assure yourself and the FDA that you are making the exact product you made at the pilot plant. It sounds simple, but problems can arise, for instance, in going from a 1- to a 1,000-liter fermenter.

Easily accessible mechanical equipment increases the probability that FDA validation will occur quickly.