As biopharma companies race to develop drugs and vaccines at “pandemic speed,” quality control strategies and shift-to-shift communications must keep pace. It is all about managing people, processes, and technology. With the increasing number and complexity of drug products – including biologics, sterile injectables, cell therapies and vaccines, it has become evident that pharmaceutical and biotech companies are experiencing extraordinary challenges arising from disruption in supply chains and the need to change business processes to accommodate social distancing, remote working, and quarantining.
In these unparalleled times, pharmaceutical companies are finding it is critical to invest in stronger communications and more collaboration amongst their production teams, which are often dispersed and working around the clock in shifts. Drug development processes from lab to launch have always relied on their teams to communicate face to face (F2F). This is especially true for pharmaceutical manufacturing operating continuously. In fact, with the impending need for largescale vaccine production, many pharmaceutical companies must equip themselves with the right tools and systems to automate and instantly capture vital communications and key information during shift handovers.
Prior to COVID-19, regulatory requirements were key contributing factors supporting the automation of data capture between shifts. In addition, the myriad of systems like Manufacturing Execution Systems (MES), Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) systems are integrated to deliver key information to personnel on the manufacturing lines. These systems can relay vital information about production performance or quality that quite often would normally require human intervention or acknowledgement.
Second Shift Perspective: Manufacturing Cleanroom Automation Operators
Pharmaceutical production has been faced with a task of changing operations to facilitate production of products related to the pandemic. The industry has been in constant transition from producing block-buster medicines towards personalized medicine to break-through vaccines, which for production teams, means there will be increasing variations in the production processes. Agility and flexibility are paramount during these trying times.
For instance, one biopharma company originally focused on automating microbial quality control quickly expanded after COVID-19 to deliver contaminant testing for pharmaceutical and vaccine manufacturing. And like many pharmaceutical companies, the need for digitizing shift management became more dire as this pandemic ignited the need to shorten the supply chain for critical drugs and vaccines while enabling biopharmaceutical companies to operate their manufacturing facilities with reduced staff.
In this example of a pharmaceutical manufacturer focused on microbial quality control and contaminant testing, the second-shift manufacturing cleanroom automation operators needed better communications with its third shift to ensure safe operations of its automation lines to target overall equipment effectiveness (OEE) conditions and deliver a quality product to customers. Any silo of communication among shifts could mean a decrease in quality in the production of cell culture cassettes and the potential loss of customers.
Cleanroom operators conduct manufacturing in a cleanroom environment (ISO 8) and carry out line cleaning, machine/process set up, web line set up and basic maintenance tasks related to the automation line. It’s vital that all manufacturing shifts communicate and work safely according to the company and OSHA guidelines. They must communicate and follow quality guidelines, work instructions, and must effectively complete all required documentation.
These operators perform machine set up, cleaning, and maintenance of complex automation lines, and the transition from second to third shift is critical. This is because operators can deliver key knowledge on any past operating patterns or any background details needed to make proper machine adjustments that can impact quality and performance. The processes they must oversee are complicated such as monitoring and reacting to multiple simultaneous machine suboperations, such as mixing, granulation, filling, etc.
In addition, the second shift operators need to communicate to the third shift all the aseptic techniques they have performed and enforced while following the Standard Operating Procedures (SOPs) for the filling operation. In conjunction with cross-functional teams, all cleanroom automation operators must work collaboratively to reinvestigate failures and perform Corrective Action Preventive Action (CAPA) investigations. A reliable handover from one shift to another is a critical component to complete validations in a timely manner and ensure all relevant paperwork is completed. There is also effort made for conducting continuous improvement and accommodating a shifting work schedule for periods as needed -- where they may need to work a 4 day/10-hour schedule or a 5 day/8-hour schedule, for example.
The Silver Lining: Communication and Collaboration
There is nothing like a pandemic to truly test the waters on how well your communication strategies are working. With COVID-19 bringing the requirement for social distancing and remote working, many gaps in formal communication have luckily been exposed. While the pandemic has made us aware of how weak our formal communication processes are, on a more positive note, it has also brought to light how we can strengthen our communications. For instance, it’s important to make communication easy by making it easy to capture, collect and store shift notes, tasks and directives.
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Pharmaceutical manufacturing teams usually require a lot of F2F communication and are used to working together. It is so important to develop up-front an approach on how information can be shared within the team and how the team-to-team communication should work. Management cannot afford to be “late” to notice potential issues and need to catch and address communication issues before they develop into real problems.
Keeping a flexible configuration where forms can be easily customized to the team’s requirements means a faster adoption and better communication. With the need to pull pertinent information from multiple systems to share within production teams, open interfaces have been shown to enable easy integration to other systems. The pandemic also showed how shift operations should be more securely documented, auditable and tamper-proof. Holes that may have been missed have been uncovered, especially where documents need to conform to GxP (good practice quality guidelines) and the FDA’s requirements.
Navigating the Transition from Crisis Response to the “Next Normal”
Protecting employees and keeping everyone safe is paramount. This can be done by formalizing and instilling operating guidelines, processes and tools that help ensure employees are kept safe. Employee confidence can be developed through effective, bi-directional communication that responds to employees’ concerns using effective tools. It is important to model the way a biopharma facility should react in advance of any fluctuations and have a system in place to enable fact-based decision making. Biopharma companies have no choice but to manage production from a distance, perhaps with a skeletal crew or more remote communications using Teams or Zoom.
While issues and resolutions may have been discussed in the break room in the past, this can’t happen during our new normal. Extra attention needs to be applied to ensuring more communication is being logged and shared among the team. Colleagues may need to read the communication from home. There may be questions about who should perform the task and clearly understand why it is being performed. Communications shared verbally are often much more convenient. However, when you have a pandemic, all bets are off.
Big Pharma’s Perspective
Roche, which was recently reported by ProClinical to hold the top spot in 2020, surpassing Pfizer as the biggest pharmaceutical company in the world, is at the forefront in utilizing tools for digitizing communications to deal with social distancing and remotely working teams. Roche's very own Mathias Gerchel gave his first account describing many of their communication issues we have touched upon in this article.
Roche Pharma mitigated risks of shift-to-shift contamination substantially by switching to virtual shift handovers and reducing personal visits to sites by supporting remote teams to work efficiently around the clock, across the globe using tools for rapid response, virtual shift handovers and cloud-based information sharing. The company was able to transition from multiple tools and applications to just the one solution that met all their needs.
Anticipating, inspiring and customizing organizational change management among shift operators can separate leaders from those left behind as seen with Roche and how they dealt with challenges stemming from the pandemic. Employee-centric workflows provided a critical competitive advantage and helped shift teams embrace change. With change management, the person creating the communication (the sender) had to learn how to describe, classify and give the right context with regards to what would need to be communicated. The receiver of the communication needs to immediately understand the context they receive as well as register and record their reaction. This is something that needs to be learned, as it is not automatic or as simple as talking in the break room, receiving a quick email or having a short chat.
Automating at a Pandemic Speed
Through automation, shifts can now access an intuitive shift handover system that ensures all legal and compliance standards are being met. For instance, audit trails have accessible auditable data storage with chronological change history, since that often causes a note of contention. All those working in a shift find that it is helpful to have all events visible at any time. The management review process is also made easier because acknowledgements can be made very simply through counter signatories.
By deploying a shift handover management system that allows operators to easily conform to Current Good Manufacturing Practice (cGMP), which is enforced by the FDA. cGMP outlines systems that assure appropriate design, monitoring and control of manufacturing processes and production. Observance of cGMP regulations assures the identity, strength, quality and purity of drug products by requiring that pharmaceutical manufacturers ensure adequate control of manufacturing operations through the use of quality management systems, procuring quality raw materials, establishing robust operating procedures, investigating any product quality deviations and maintaining dependable testing laboratories.
Formalizing a system of controls, when sufficiently put into practice, helps to prevent instances of contamination, mix-ups, errors, deviations and failures, assuring the drugs produced meet quality standards. Adherence to cGMP and FDA 21 CFR 11 will allow any issues to be quickly pointed out and addressed – often resulting in faster and better decision making.
Continuous Manufacturing Facilities
In the pharmaceutical industry, continuous manufacturing - otherwise known as batch-less manufacturing is used primarily to produce over-the-counter products like personal care items due to the added complexity in ensuring quality as it is not as easily checked for error as batch-manufacturing. The FDA estimates that continuous manufacturing can produce a drug in a day while batch production can take months due to the constant set up and break down of processes between batches to ensure quality and compliance are adhered.
In continuous environments, the increasing amount of documentation and systems makes it more difficult to have everybody on the same page. Such environments require transparency to be increased. Identifying the anomalies and being able to quickly check their status is vital. Even though pharma production processes are highly structured, not everything is always covered. There are always ad-hoc things to do and communicating the who, what, where, why and when while social distancing or working remotely is key.
The Result of Digitized Communications
Though production teams and managers use communication skills daily, they may not realize just how much their communication impacts pharma’s success. Communication dictates how well people throughout pharmaceutical manufacturing coordinate their efforts to create quality products. Shift communication can potentially have an enormous impact on a pharmaceutical manufacturer's productivity, profits and workplace attitude.
Digitizing and automating shift handovers has become more important than ever because it can result in improved pharmaceutical production, increased performance, reduced risks and saved time. Additionally, it helps avoid potential communication disconnects among teams.
Author Biography
Andreas Eschbach is the founder and CEO of the software company eschbach (www.eschbach.com), which helps production teams stay safe and work smarter through better information sharing and collaboration. Holding a degree in computer science, he draws his practical experience from leading a variety of international software consulting, and implementation projects for leading chemical manufacturing companies, focusing on production, continuous improvement, EHS, and maintenance. His company is a provider of manufacturing solutions and headquartered in southern Germany with offices in Boston, Massachusetts.