When 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
This idea of “white
space” – gaps – is not new, but it is worth resurrecting, as it was by Timothy
Tyson, CEO of Aptuit, at a recent 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 know and prove
that the product was not compromised by out-of-temperature specifications.
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.
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.
reviewing critical systems, processes and procedures, ask yourself:
What are the
levels of risk?
Do I know the
Are my records
complete and trustworthy?
Is the data
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
Seek out your
white spaces, fill the gaps and reduce risk and cost.
comprehensive reliable, high-quality measurement and monitoring solutions in
controlled environments within the life science industries. Vaisala helps
customers protect medicines in the supply chain with mapping and monitoring of
temperature and humidity in containers and warehouses. For more information
about Vaisala, visit www.vaisala.com.