By KEN APPEL, Manager of Regulated Markets, Vaisala

KEN APPELWhen the stakes are high, uncertainty and risk go hand in hand. With regard to human and animal health, understanding where gaps exist in procedures, information and knowledge is critical.

This idea of “white space” — gaps — is not new, but it is worth resurrecting, as it was by Timothy Tyson, CEO of Aptuit, at an International Society for Pharmaceutical Engineers conference. Tyson challenged the leadership in pharmaceutical companies to reassess quality across the whole environment. His wakeup call to industry was focused on showing more commitment to quality by being innovative and science based, as well as reducing the costs and increasing the ability to bring new drugs to market. In general, he advised looking for the “white space” across the spectrum from development to manufacturing.

 Let’s zero in on a specific example of uncertainty and gaps (white space) in continuous monitoring of critical temperature environments. In this case, the word continuous means there is an uninterrupted flow of data for a particular monitored space. Even in an ideal world of stable measurements and infrastructure, you must understand the sources of uncertainty and where gaps can occur. If the power goes out or the network goes down in a facility or a monitored area, you should always be gathering real-time data because you will need to know and prove that the product was not compromised by out-of-temperature specifications.

Getting complete information is good, but are records really complete if they are not accessible by alert notices to a problem, or on demand for FDA inspections? Obtaining records when you need them is essential to maintaining quality and dealing with problems quickly. For example, how fast can you respond to an on-site FDA request for warehouse temperature data on a holiday 18 months ago? If you have the appropriate system in place, the answer is “immediately.” When do you know it’s time to check the compressors of specimen freezers? The answer is by reviewing historical trends that show degradation of temperature control.

Acquiring a continuous flow of data is important. But is the data correct? There are uncertainties and associated information with every measurement of temperature, humidity or other parameter. From calibration uncertainties, calibration intervals and next calibration date to if the instrument was found to be within calibration, who maintained the instrument and if it is validated, you need to know the answers. These should all be a part of your monitoring system records.

The better your metrics, the easier it is to know whether you are in compliance or not. Reducing uncertainty means that you can move resources away from reporting deviations and the actions that follow to more proactive measures on improving quality. It also reduces the cost of compliance because you have the data and metrics to support your case. Regulators want to see that your processes and products are in a state of control.

When you’re reviewing critical systems, processes and procedures, ask yourself:

  1. What are the levels of risk?
  2. Do I know the uncertainties?
  3. Are my records complete and trustworthy?
  4. Is the data correct?
  5. Are the metrics communicated to those next in line to handle the product, to management, to your customer, or to anywhere in the organization that could help make better decisions?

Seek out your white spaces, fill the gaps and reduce risk and cost.
