In the article below, Chris Forsdyke, executive director, PPD® Laboratories’ GMP lab in Athlone, Ireland, details why proactivity is important even in a regulated laboratory environment.
You may have read the title of this post — Proactivity in a GMP Contract Laboratory — and wondered, “Why do you need proactivity when you are working in a regulated laboratory environment, bursting with procedures, standards and well-defined processes?”
Let’s start with the key attributes of a contract good manufacturing practice (GMP) laboratory.
Analytical performance and approaches
First, a competent GMP laboratory can be defined by its analytical performance supporting pharmaceutical manufacturing operations and overall testing coverage. Essentially that’s the ability to get things done right the first time with competitive turnaround times that integrate with third-party manufacturing and/or supply chain operations. For mature expert GMP labs, associated personnel and combined capabilities are expected to be able to work at an elevated level of support. In other words, not just interacting with well-defined testing programs, but possessing a strong knowledge and application of chemistry manufacturing controls (CMC) and required analytical control strategies – all of which can be offered as a value-added proposition to the client.
Second, pharmaceutical manufacturing and supply chain scenarios closely aligned and central to drug release testing strategies require proactive analytical approaches in a timely fashion. That’s because a product or process is dependent upon the laboratory output and related conclusions from validated and verified testing data. This creates a link beyond the realm of just the contracted work between the contract laboratory, laboratory scientists and pharma project leaders. Collectively, they drive analytical activities that verify manufacturing output and compliance with market authorizations. In routine testing this oversight generally is straightforward, but the presence of an atypical event during manufacture or an atypical result generated during quality control testing requires the analytical know-how to drive to a conclusion from a quality, scientific and overall CMC perspective.
Laboratory systems and processes
Third, at the center of the laboratory are systems and processes designed to provide clear and consistent instructions in line with the most up-to-date regulatory guidance to ensure a quality framework that encompasses a consistent testing approach. Troubleshooting is an expected occurrence and needs to be effective. But, there also are laboratory quality tools that can ensure the need to troubleshoot is minimized, or at least effective in adding value and knowledge to pharmaceutical testing programs. Troubleshooting is an ever-present requirement that needs careful, timely and considerate management, with adequate and thorough issue mechanisms able to deal with the scientific matters at hand. Well-designed quality systems and processes in conjunction with well-trained scientists, robust and validated methods, and a suitably designed laboratory facility are the key components to ensure a high-quality laboratory operation.
Fourth, the use of human error reduction processes plays a key role in this corrective and preventative approach. These processes include identifying or discounting the specific human error that may have led to an issue. Ultimately, is a change to a process necessary and what is needed to avoid a repeat of this scenario? The ability to incorporate these identified steps into approved methods or standard operating procedures as part of continual improvement efforts is vital.
In the short term, it may appear that training a good proportion of the team members in human error reduction, the 5 Whys, fishbone analysis and other tools is a time-consuming and lengthy process. However, the organization will resolve issues faster, create more robust preventive actions and improve the quality of the laboratory over the longer term.
The benefits of having troubleshooting prowess should be viewed as having the same level of importance as proficiency in the procedures themselves. Ultimately, a high-performing GMP laboratory is at the heart of the ability to supply pharmaceuticals to patients, so the ability to deliver and deal with the unplanned is crucial to maintaining key drug supplies. By being proactive and proactively incorporating the appropriate policies, procedures and practices, the GMP lab will significantly increase its potential for success.
Chris Forsdyke is executive director at PPD® Laboratories’ GMP Lab in Athlone, Ireland.