Change Management’s Impact on Innovation in the Pharma QC Laboratory
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Innovation is needed more than ever in the rapidly evolving pharmaceuticals market. Challenges, such as those presented by COVID-19, continually add to an urgent need to provide life-saving and life-enhancing medications to an expanding and diverse global population. Continuing to make these available at an affordable cost, when supply-chain, manufacturing, regulatory and distribution costs are rising significantly, increases pressure on pharma manufacturers to streamline working processes and improve efficiency in order to remain competitive.
The benefits of innovation can be significant; digitization and automation can help to reduce operational costs, simplify staff training procedures, manage and secure data, and improve laboratory productivity. However, regulatory concerns may be a disincentive to innovate and change. Risk-averse laboratory staff can be reluctant to change established and proven technologies and processes, often citing regulatory expectations as a restriction. Sometimes, analytical laboratory management can feel beholden to narrow standard operating procedures (SOPs) which are often instrumentation-specific, and change and the accompanied gaining of regulatory approval can be seen as disruptive, costly or even unnecessary.
This resistance to change could have a significant impact on quality and efficiency. Many pharma companies have investigated and quantified the error rates in the laboratory, and it is estimated that around 50% can be assigned to human errors.1 It has been reported that the human error rate can be reduced by up to 40% by identifying and addressing the root causes of these errors.1 Integrating smarter procedures allows technology to lessen the burden of human input, and error-proofing practices and competence training can result in fewer errors. The mitigating or preventative actions may require changes to established SOPs, including modernization of analytical methods, automation or the introduction of modern software or instruments. These actions require documented assessment as part of a change management process before they can be introduced into a validated procedure.
Change management is becoming an increasingly important part of company culture. With effective change management programs in place, it is possible to introduce innovation or new approaches with minimal disruption to staff and reap significant benefits, even in the heavily regulated pharma industry.
The drive to stay current
To ensure continuous improvement, it is important for every pharmaceutical organization to have a sound change management framework in place. In fact, Heather Longden, an independent regulatory compliance consultant, says that in the current pharma manufacturing environment, regulators actively desire to see improvements, especially when these can impact access to quality medicines: “The regulators are encouraging innovation, provided of course it is done correctly.”
Rob Hughes, company director at Rob Hughes Associates, agrees. During his time working at a global biopharmaceutical organization, Rob found that discussing the implications of proposed changes with regulators early and throughout the process allowed him to successfully manage the introduction of a novel real-time release regime of a new tablet manufacturing process – leveraging a “new” concept into an existing traditional manufacturing scenario. “It was easy for us to measure the impact of the changes because we built the measurement of ROI into our strategy,” he says. By integrating quality testing of critical quality attributes (CQAs) into the manufacturing process itself, they were able to remove QC testing at the end of the process – and satisfy the regulators that they were continuing to create a quality product. “Their involvement in the journey meant they could actually suggest aspects we could do differently to make the scheme a success. It helped us get ahead of the guidance and speed up the process,” he says.
For Rob and team, these changes meant an acceleration of product supply for patients without increasing the risk to those patients. “The bottom line is: any changes need to put the patient first, then the regulators, then the business,” he says. “Regulators would agree that patients should always be the priority.”
Heather Longden emphasized, “regulations require companies to keep their technology and instrumentation up to date. Certain equipment or materials will not be available forever. If you don’t prioritize a change management plan, change will happen to you, rather than working for you,” she says. “We should always remember that the ‘c’ in cGMP stands for ‘current’.”
Creating a change culture
Return on investment (ROI) is a key consideration at the beginning of any change project, both to show management that proposed changes are in line with company objectives, and to demonstrate the value of the eventual change to people working in the laboratory. However, when considering the impact of human error and data integrity, that ROI can manifest directly or indirectly, explains Danielle Kehoe, production manager at Waters’ Wexford manufacturing site.
“There is so much potential for human error – which of course means we could be proceeding with the incorrect information, impacting the quality of our products, or incorrect data which will negatively burden quality review cycles, hence our release time,” she says. “A good ROI can also mean protecting data integrity, making sure quality is maintained, and ensuring compliance.”
At the Wexford site, Danielle’s colleague Paul Daly oversaw the introduction of NuGenesis™, an analytical lab management system that replaced physical notebooks with an electronic counterpart. The Wexford site operates to ISO13485 standards, and follows 21 CFR Part 11, so it is regulated similarly to many of Waters’ customers. Paul believes that transparency in change management played an important role in the success of the project: “We involved staff from the start,” he says. “We were transparent about why we needed change, primarily to protect our data integrity, how we were going to implement that change, and the potential impact on the running of the lab. Now if we were to ask our team if they’d go back to the old method they’d say, ‘No way!’”
Danielle Kehoe adds that the key to getting “buy in” from the staff was showing them there were people and resources dedicated to making the changes happen. “We were able to show that by reducing the burden of QA [Quality Assurance] review, our increased data integrity would benefit the company – but would also make their day-to-day jobs easier.”
Paul Daly says that involving staff in the process and allowing them to see the tangible benefits helped make them feel more accountable with regard to ALCOA+. “A few people have the attitude that ‘it works fine as it is, so why change anything?’, that’s why it’s important to involve those people from the very beginning,” he says. “In our case, the team could see that by building intelligence into our logbooks, we had removed a complicated review step and were still able to maintain our data integrity.”
In fact, contributions from the team should be encouraged, Rob Hughes says. “It’s about culture. In any good organization there should be an ongoing dialogue with respect to change. It’s not just about satisfying regulators, management, and company-wide objectives – it’s how the organization operates from the grassroots up.”
At Waters’ Wexford site, the “Ideas Program” encourages staff to suggest ideas to a committee (including a risk assessor) for evaluation – something that Danielle says has positively impacted the business culture. “We’ve even gone back to the first forms we put in place, and asked for further feedback: ‘Can we make this even easier? Can we get a little more productivity improvement?’ It reassures people that we are open to their input, and that they can play a part in improving the running of the lab.”
Despite there being barriers to change, the pharmaceutical manufacturing industry in general is more ready than ever for new, innovative technologies to enter the market, something made increasingly possible due to more progressive regulation, and a willingness to adopt the latest advances in manufacturing and control processes.
It is imperative that proactive, documented change management is at the heart of any innovation strategy. By working alongside quality assurance/control staff and regulators, and including them in the process, change coordinators aim for smooth and dynamic adjustments to laboratory procedures, to create an environment where staff are supportive of updates to existing processes. The resulting improvements have the potential to minimize errors in analytical measurements, reduce accidental human errors or instrument malfunctions, improve workflows, and ultimately accelerate the supply of products to patients.
1. Bodmann K, Reinhard C, Mödler M, Tinson K, Johnson M. Lonza error prevention system (EPS) – changing human performance in pharmaceutical operations. Chimia. 2016;70(9):610. doi: 10.2533/chimia.2016.610
About the authors:
Stephanie Harden is manager, product marketing, QA/QC portfolio, Waters.
Heather Longden is an independent regulatory compliance consultant.