While there is no magic crystal ball to tell us just what the year ahead has in store, one thing is for sure: technology will continue to change the way we do, well, everything. And of course, pharmaceutical manufacturing is no exception. A new MasterControl white paper discusses the trends pharma manufacturers should prepare for in 2019, particularly as they relate to the business-critical – and notoriously inefficient – batch record process.
Breakthrough tech initiatives such as the Industrial Internet of Things (IIoT), robotic process automation and artificial intelligence (AI), to name just a few, are taking hold in every area of manufacturing, from product assembly and quality inspection to equipment maintenance and even manufacturing documentation.
To avoid becoming overwhelmed by these game-changing advances, experts encourage manufacturers embarking on their digital transformation journey to identify business-critical processes and make strategic, incremental changes in these areas.
“Start the journey with steps that will achieve near-term value, while laying the foundation for new business opportunities that will come from interconnectivity and a broad access to data and information,” said the global chair of KPMG’s Industrial Manufacturing Sector in its recent Global Manufacturing Outlook report(1).
The batch record process is essential to releasing product to market, and critical for compliance. And because many companies still compile, maintain and store their batch records in paper form, it’s a process ripe for digital transformation. With the arrival of innovative new electronic batch record (EBR) solutions, optimizing the batch record process should be a point of emphasis in the coming year.
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It’s worth noting that companies use many different terms for their manufacturing documentation, such as production records, travelers, lot history records, genealogy records, batch records, recipe management, etc. Each refers to the expansive records that document every operation performed throughout the production lifecycle of each product batch. Regardless of terminology, the factory floor operators, document control specialists and quality professionals involved in the manufacturing documentation process will agree that there is really nothing sweet about it – especially if it’s paper-based.
Though the terms are interchangeable, we’ve found that many pharma companies refer to their manufacturing documentation as batch records, so we follow suit in this article.
When data is trapped in paper documentation, as it often is in pharma manufacturing, it requires a significant effort to access and leverage it, or worse, it’s lost altogether. In contrast, when manufacturing data points across the enterprise are digitized and connected by IIoT and analyzed by pattern-perceiving AI algorithms, data becomes the major driving force of all production activities. That’s why the promise of digital transformation – namely, greater access to actionable data – is so compelling in this industry, particularly in relation to batch records.
Because batch records are the official system of record for data related to the manufacturing process, compiling information from all areas of the business, they constitute a logical link between enterprise systems. When digitized and connected, these data-rich documents can streamline processes and provide access to powerful insights that can completely change the way pharma manufacturers operate.
“The data-driven insights that can be gained by integrating the batch record with the quality system represent a huge benefit to pharma manufacturers,” Terrance Holbrook, a manufacturing veteran and senior product manager at MasterControl, told GxP Lifeline. “They enable proactive versus reactive quality, pinpointing production issues in real time so manufacturing personnel can address them and take the necessary measures to prevent them from happening in the future.”
The sector’s dependence on data will only increase in 2019 as new technologies emerge, existing ones become more established and commonplace, and more companies embark on their digital transformation journey.
When a company implements a new technology or system, it serves as an opportunity to evaluate existing processes and tools in the impacted areas of business, assess strengths and weaknesses, and determine how the newly acquired system will change the way work is done. Holbrook observes this consistently as he helps manufacturers transition from paper to EBR solutions.
“Because they’re completely recreating their master templates, it’s an opportunity for them to really look closely at what works and what doesn’t,” Holbrook explained. “Process improvement will be big when it comes to batch record execution.”
In 2019, companies will prioritize harmonizing their batch records across global sites, a process improvement facilitated by the digitization of batch records. Companies transitioning to an EBR solution, particularly during the system configuration and data migration phases, are able to evaluate and harmonize batch record processes across departments and global sites and establish corporate standards. Doing so improves efficiency, quality and regulatory compliance alike.
Ultimately, EBR-driven process improvements will enable the manufacturing organization to do what it does best: produce quality at the source. As more companies transition to an EBR solution, they will rely on this technology to generate the proof of quality automatically and in a fully compliant format regardless of regional requirements, removing the documentation burden from both the manufacturing and quality departments.
Like the industrial revolutions before it, Industry 4.0 is triggering changes that are seen by some as a threat to the role of humans in manufacturing.
However, quite the opposite is proving to be true. In 2019, manufacturing companies should expect the role of workers not to be superseded by machines and technology, but to be reimagined with the onset of Industry 5.0.
“Successful transformation is all about people,” according to KPMG’s latest Global Manufacturing Outlook report(1). “You need to invest in people and create an innovative mindset, involving training and enablement. These elements are more important than implementing the technologies. If people don’t get excited about transformation, it won’t be successful.”
Manufacturers have long expressed a desire to reallocate highly skilled operators and quality professionals to more value-add tasks than, for example, manually creating and validating documentation. With respect to batch record processes, the goal of digitization, automation and integration is to minimize the interface between humans, machines and paper(2), allowing personnel to focus their efforts on measuring and improving the quality of the product instead of the quality of the documentation. This will serve as a competitive differentiator for companies that adopt an EBR solution in the coming year.
In 1997, the U.S. Food and Drug Administration (FDA) issued its final 21 CFR Part 11(3), which established that electronic records and signatures were equivalent to those executed on paper. Though not new to pharma manufacturing, the concept of paperless documentation remains difficult to fully execute, with the batch record process being largely to blame.
“True paperless is hard, and it’s further reaching than companies often realize,” Holbrook said. “After getting a manufacturing line up and running, companies discover other elements – log books, inspections, etc. – that they haven’t fully accounted for. It’s not as simple as connecting [a manufacturing execution system (MES)] to the line, because MES can only do so much paperless.”
In the year ahead, expect the pace of digitization and the adoption of emerging technologies to quicken(4) in all areas of manufacturing, including the traditionally paper-based batch record process, thanks to the arrival of new EBR solutions capable of bringing the factory floor to a truly paperless state.
The biggest takeaway from this list is that batch records will garner more attention in 2019. And considering most companies report product holding times of days, weeks or even months due to delays in batch record review and release activities, this heightened focus is long overdue. Those companies that can streamline their batch record processes with the help of an EBR solution will get to market faster, and with higher quality product, than the competition.
1. Global Manufacturing Outlook: Transforming for a Digitally Connected Future. 2018. KPMG International.
2. How Might Biopharma Manufacturing Differ in the Next Decade? 2018. Life Science Leader.
3. 21 CFR Part 11. 2018. U.S. Food and Drug Administration.
4. Industrial Manufacturing Trends 2018-19: New Strategies for IoT Investment. 2018. PricewaterhouseCoopers.