With the FDA under fire in recent years regarding the quality of inspections, the effect on biotech, pharmaceutical, and medical device companies has been to err on the safe side of regulatory requirements by proving more evidence wherever they can. While this is a logical reaction, there is a risk that companies may be placing extra burdens on facilities, operations, and quality control departments. As companies seek to attain the high standards set by the FDA and associated agencies, how can they be sure they are solving the right problem?

What is the best way to decipher the guidelines from the FDA with respect to controlled environments, specifically 21 CFR Parts 210, 211, and 820? To assist with the thought process, I would like to explore that question through the example of real world facilities, taking a closer look at the requirements for design, monitoring, and control and how they relate to the product being manufactured or processed.

In some cases, facilities have been designed to a higher classification than required and facilities and operations departments are asked to operate and maintain their facilities according to strict ISO guidelines. Quality Assurance departments are asked to translate, impose, monitor, and enforce general guidelines provided by the FDA to ensure their companies have a speedy and 483-free inspection.

First, let’s refer to the Code of Regulations (CFR) associated with controlled environments within the biotech, pharmaceutical, and medical device industries, in particular 21 CFR Parts 211.42, 211.46, and 820.130. 21 CFR Part 211.42 contains guidelines for the design and construction of the facility with respect to operations within the facility, while 21 CFR Part 211.46 focuses solely on the Heating, Ventilation, and Air Conditioning (HVAC) design. 21 CFR 820.130 pertains to the packaging of medical devices.

The key is to focus on the products and the processes that are being performed in the facility. This approach allows us to solve the issue of what is required for the facility and product rather than follow non-specific guidelines that may have no bearing.