In general, what are some data integrity concerns pharmaceutical manufacturers have concerning their Environmental Monitoring (EM), Microbial Limit Testing (MLT), sterility testing, and endotoxin testing procedures?
The modern microbiology laboratory is a complex system of inputs and outputs that culminate in a decision being made about the quality or suitability of a product based on the data collected. This is just one reason that it’s so important for modern laboratories to adopt behaviors and policies that encourage a strong stance on data integrity, as data is the backbone of all the decisions we make as microbiologists. In my experience, the most common data integrity issues that are encountered everyday can be broken down into two categories: software/electronic data compliance, and the inherent risk for human error in very subjective or manual laboratory processes. As an industry, taking a step back and looking critically at our current processes and methods, it’s clear that many of these methods are considered antiquated in the face of how our quality management systems and manufacturing processes have evolved over time. It is therefore imperative that we start to look at ways that we can modernize the laboratory with process improvements to solidify our data integrity compliance, enabling us to keep our medicines safe and our patients healthy.
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As pharmaceutical manufacturers are now capable of collecting more data from their monitoring and testing systems, what issues, or problems has this data “explosion” caused?
There are two aspects of the “data explosion” that need to be addressed to answer this question; they include how data is collected in the current laboratory landscape and what decisions are being made as a result of that collection. Many of our current laboratory assays involve a heavy reliance on antiquated processes that involve many human-dependent steps and subjective judgement calls. We as an industry must strive to reduce the risk for human error, because this directly impacts the data we use to make decisions about product quality and in turn impacts our ability to keep our patients safe. Current research suggests that mitigating the risk for human error stems from a systematic investigation into the root cause and subsequent process re-engineering from subjective human-dependent assays to more objective automated assays and processes. The second aspect we must consider is how we use data to make decisions about product quality, solve problems, and reduce process variability in the laboratory and beyond. It’s becoming more important that we utilize the tools at our disposal, whether they be electronic or strategic, in letting data drive the decisions we make about product quality and patient safety.
As a supplier of equipment and expertise to pharmaceutical manufacturers, what specific tools and technologies do you offer to help companies manage, evaluate, and turn their collected data into actionable information?
One key aspect of rapid microbiological methods is that many of them work to transition laboratories from assays that are very subjective with many manual steps, to ones that are objective and quantitative, while reducing the human hands-on element of the traditional assay. One good example of this is the Nexus Automated Endotoxin Testing System. This system combines endotoxin cartridge technology with a fully automated liquid handling and testing platform. Increasingly, automation is moving from the manufacturing floor to the laboratory and is relied upon to increase laboratory efficiency and optimize assay workflow. With human error reduction being a critical key to data integrity compliance, it is no surprise that laboratory automation is seen as a major solution. Another effective strategy for controlling a firm’s data integrity risk is to utilize electronic data tracking and trending tools that enable a firm to make effective decisions. One example of this is the tracking and trending tools for EM related data available with Accugenix microbial IDs. Another example is the Cortex software for endotoxin data tracking and trending.
In particular, can you tell us how data integrity is perhaps the most important aspect of EM, MLT, sterility testing, and endotoxin testing data collection? What is Charles River doing to help companies ensure the integrity of their monitoring and testing data?
Data integrity is a concept that takes root in the very core and fabric of cGMP regulation. Product quality and patient safety are determined and confirmed based upon the data we collect in the laboratory. The integrity of that data is essential to enabling organizations to defend the decisions they make about the critical-to-quality aspects of their products as well as investigate and drive to root cause when problems arise. It’s for these combined reasons that I think data integrity is perhaps one of the most important aspects of our everyday work; because it’s the right thing to do for the safety and health of the patients we serve. We as an industry need to ensure that a culture of continuous improvement is established everywhere within our data integrity strategies, where investigating, driving to root cause, and using data to justify decision-making is a key priority of the quality organization overall. We also need to ensure that we are empowering and encouraging the move to automated and rapid microbiological technologies that reduce our risk for human errors, allow for quantitative real-time data measurement, and enable data-driven decisions to be made about product quality and patient safety.
Looking ahead, can you tell us how Charles River will continue to meet the needs of its current and future customers in terms of managing their monitoring and testing data in general and data integrity specifically?
Charles River has always been, and will continue to be, the leading innovator in our industry. Our goal is to continually design products that ensure the highest levels of data accuracy, coupled to the lowest levels of human error achievable. Our current portfolio of products will continue to evolve to meet changing regulations and the ever-growing needs of our customers. Recently launched products as well as those in development have been designed with data integrity compliance at the forefront, and we will continue to endeavor to exceed regulatory standards whenever possible.
Author Biography
Matthew received his Bachelor of Science degree in microbiology from the University of Massachusetts Amherst and his Master of Business Administration degree in Six Sigma / Quality Management from Southern New Hampshire University. Matthew has over 10 years of experience in Quality Control Microbiology, Regulatory Compliance, Pharmaceutical Investigations, and Manufacturing Science. Matthew’s other industry experience includes:
- Utilizing Six Sigma and DMAIC methodologies to drive to root cause of complex quality control and manufacturing problems.
- Leading cross-functional investigation teams.
- Leading method development and validation teams in the quality control microbiology laboratory space.
- Leading beta testing teams for new and complex laboratory instrumentation.
As a Product Specialist for Charles River’s Microbial Solutions division, Matthew provides technical expertise that enables customers to implement innovative rapid micro solutions for endotoxin testing, microbial identification, and microbial detection. Matthew is based in Atlanta, GA, USA.