Picture the situation you like to picture least…
A drug your company manufactures is suspected of causing a rash of untimely deaths. A recall is initiated, an FDA investigation is launched, and personal injury attorneys start readying their suits. Every aspect of your operation goes under the microscope, so to speak, and that’s when you learn that your plant’s ‘rigorous’ quality control protocols for compliance (FDA GMP and 21 CFR Part 11) were not that ‘rigorous” after all…
Not that rigorous? Anathema though this thought may be to most pharmaceutical quality managers, it is nonetheless quite apparent to companies such as ours, which make products critical to maintaining quality in pharmaceutical and a wide range of other applications.
A glaring example is in the case of instrument calibrations, and in understanding why “BEFORE” data is needed to make your company not only FDA-compliant but also relatively immune from negligence suits.
The crux of the issue is whether you can demonstrate that the instruments you use for pharmaceutical processing are accurate, a requirement of FDA 21 CFR Part 11, and GMP guidelines. As most know, temperature and humidity data
loggers and chart recorders need to be recalibrated periodically to ensure this accuracy, and competent quality managers need to establish schedules for recalibrations that reflect due diligence to monitor that temperatures and humidity are kept within acceptable and pre-defined tolerances.
But “recalibration” can mean different things, and what could be termed “recalibration on the cheap” does NOT demonstrate the accuracy of your recorded data (instruments). ‘Recalibrations on the cheap’ refers to ones that re-set an instrument to the desired accuracy without first determining whether the instrument was in or out of acceptable range prior to recalibrating. Determining an instrument’s accuracy before it is recalibrated is clearly an extra step and usually costs more than a simple re-calibration. However, such “BEFORE” data is the only thing that will help you determine and demonstrate that your instrument was operating in acceptable ranges during the entirety of your manufacturing operation, OR, potentially be alerted to possible temperature or humidity fluctuations that jeopardize product quality and necessitate considerations of recalls BEFORE clinical problems ensue.
Admittedly, the mere existence of recalibration services that do not include determinations of “BEFORE” data can mislead those who do not consider that recalibration services, whether from manufacturers or laboratories, serve a wide swath of industries, including those where less costly recalibrations may be a more appropriate match. A museum archivist, for example, may want to keep his mummies intact and employ an identical data logger to help do so, but no matter how treasured the museum archive and collection may be, a museum curator is just not faced with the same liabilities as a pharmaceutical manufacturer.
Compliance expert and recent Pharmaceutical Processing contributor Bill Burke, President of Merit Solutions (www.meritsolutions.com) comments that this misunderstanding of requirements for “BEFORE” data undermines many pharmaceutical manufacturers’ implementation of 21 CFR Part 11 compliant information systems as well. Burke reports, “We find that many understand they need an audit trail but that they are lost when it comes to understanding what that audit trail must capture. This is very comparable to the situation with instrument calibrations. If I make a change in the electronic record, e.g. saying I took a batch out of quarantine on June 1, I need to be able to also show the status BEFORE I made that change. We ran into one Canadian manufacturer that was selling into the United States that recorded such changes by streaming data in big fat files of strings of numbers, which they could not possibly translate into a printed record of what existed BEFORE and after a change. If they really looked at the regulations they would understand that their system was not compliant.”
Thus, BEFORE data has bearing on many aspects of pharmaceutical processing. When it comes to instrumentation for temperature and humidity tracking in pharmaceutical applications, the type of recalibration that is recommended for full FDA compliance is a full-range recalibration where multiple points are documented as found data both BEFORE and after calibration, performed by an Accredited Laboratory of the equipment manufacturer or another third party accredited source. It is important to note that third party calibration houses can only tell you how far out of calibration your instrument is, but usually only a manufacturer with the equipment, software or product knowledge can actually recalibrate your instruments to ensure they meet original specifications. In recent years, we have observed both positive and negative trends when it comes to pharmaceutical industry practices vis-à-vis recalibrations, above and beyond the lingering misunderstandings of the importance of BEFORE data.
On the plus side, the existence of free services such as Dickson’s Calibration Club ( www.dicksondata.com ) have eliminated the prior problems in some pharmaceutical plants where needed calibration schedules got lost in the fray of day-to-day crises and production challenges.
On the negative side, the crumbling U.S. electrical infrastructure has added to problems in creating stable plant conditions, newly challenging pharmaceutical manufacturers as others where temperature and humidity affect critical storage. A recent study conducted by Lawrence Berkeley National Laboratory reported an estimated $80 billion a year cost to the U.S. by power interruptions. The major failures of the electrical grid may have grabbed the headlines, but the smaller power outages have also been quite frequent. Unwitting pharmaceutical manufacturers may have jeopardized inventory because of these mini-power outages. Those without BEFORE data on their instruments have special reason to worry-and ACT!
by Chris Sorensen, VP, Dickson Company
About the Author: Chris Sorensen is VP of Dickson Company (www.dicksondata.com), which offers the widest range of data loggers and chart recorders available in the world for pharmaceutical and other applications.
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As published in Pharmaceutical Processing magazine (8/2005).Tags: dickson