Here is a familiar demand: “Show me where in the regulations it says to do that!” If you’ve spent any time in Quality, working on a facility or equipment project in the pharmaceutical industry, you have certainly had that put to you at some point. And why not?

Far and away, what most people (including our industry engineers, technicians, and operators) think about when they think “Quality” is “Compliance with Regulations.” Compliance is certainly an issue of vital importance, but Quality does not stop there, and there is no time when that is more clear than during a Quality Audit. This article will show that understanding the potential audit outcomes in the future can serve as powerful design criteria today.

For many companies today, the majority of their external quality audits will not be performed by regulatory agencies, but by other companies. This company auditor has a day or two to assess the overall “quality culture” of a potential supplier or contractor. Unlike the FDA that has a free pass into all FDA-regulated facilities in the U.S. at any time, a company auditor performs the audit at the discretion of the company being audited. After this audit is complete, and provided that the auditor says everything is okay to link his company to the manufacturing processes of the other, the auditor’s company will have little to no direct experience with day-to-day processing. In short, that’s a couple of days to make a full assessment of all quality systems in a unique facility that will have to be valid for a year or more. This is a challenge for non-sterile raw material suppliers, which only grows more challenging as cleanrooms and sterility claims are added to the mix.

With so little time to assess a facility and a manufacturing process (or many of them!), how is it that auditors can effectively and thoroughly measure the strength of all Quality Systems? It is here that a large part of non-Quality personnel would answer something along the lines of “directly measure the facility against the regulations using a checklist or other tool.” Though compliance with regulations is absolutely required, measuring against regulations is a very small part of an audit. Furthermore, it is difficult to do so “directly.” How would one measure “Appropriate measures should be established and implemented to prevent cross-contamination from personnel and materials moving from one dedicated area to another”¹ directly? And how would it be done for every possible combination of personnel, materials, and products in a contract formulation and sterile liquid filling company, for example? In short, it can’t happen. Alternatively, there must be a way to achieve solid and defensible results.