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With a number of vaccine trials progressing globally, recent data loss and quality control errors have raised the importance of ensuring effective data systems in this effort
In early October, an error caused by the use of outdated XLS file formats on Microsoft’s Excel platform resulted in 16,000 Covid-19 test results being lost by Public Health England. Not only was this a potential disaster for the officials seeking to contain the spread of the virus as the UK entered a second wave, the mix up has had a huge impact on public trust of the testing system.
For those experienced in working with vast amounts of data the error, caused by the use of a format which could only handle 65,000 rows of data rather than the one-million rows Excel is capable of, was hardly a surprise.
Pharmaceutical data professionals were shocked that PHE was relying on spreadsheets for such a vital task, which are notorious for being complex, inconsistent, prone to errors, out of date, and, above all, time consuming.
In pharma manufacturing, using spreadsheets is sure to mean a lack of visibility and transparency over processes, and an inability to show where there is capacity. Having a single source of data to base decisions on, by comparison, reduces time lag and provides assurances of a standardized data set and, importantly, a single version of the truth.
It is not only the UK where challenges around data systems are appearing at the worst possible time. The FDA has found quality control challenges at some major US pharma manufacturers, which have put the brakes on efforts to secure Emergency Use Authorization (EUA) for Covid-19 vaccines and treatments.
Government inspection documents also show that inspectors who visited one manufacturer in question found that data on the plant’s manufacturing processes had been deleted and not properly audited.
These instances of data-loss and a failure to follow validated processes provide clear evidence of the need for putting the right technology and systems in place to ensure the best manufacturing procedures. I would argue that this is more important than having the means of production on standby to ramp up manufacture.
As governments around the world continue to invest in facilities to ramp up vaccine manufacturing capacity (the UK government recently invested an extra £100 million in a new state-of-the-art facility, for example), attention must also be given to how modern planning and scheduling systems can ensure manufacturing is done in the most efficient manner.
There is no doubt that the global response to the outbreak of coronavirus by the international scientific and pharma communities has been extraordinary, with more than 150 separate teams of researchers working on a vaccine and 11 potential candidates in the final stage of testing. This is not to mention the various projects underway with researchers striving to find treatments for the virus. All this, just seven months after the emergence of the novel coronavirus that has impacted pretty much all eight billion human lives on the planet.
In order for this work to continue effectively and for science to deliver a solution for the world to return to a semblance of normality, however, putting the right systems and technology in place has never been more important for pharma manufacturers.
The use of an advanced planning and scheduling (APS) system, for example, will be critical for pharma manufacturers to create a single real-time plan to reduce lead times and optimize resources. Importantly, APS systems allow manufacturers to maintain the validated process while running their plant optimally, maximizing the current and future batch yield. The granularity of data far exceeds that of spreadsheets and users are able to use this to model scenarios based on equipment, labor, materials and utilities in order to make more effective decisions.
Fortunately, few pharmaceutical companies depend entirely on spreadsheets, and employ sophisticated enterprise resource planning (ERP) systems to manage their business. However, these ERP systems, by their nature, are not designed to manage production scheduling, leading them to seek APS systems offering real-time visibility of all manufacturing processes.
Working on a single plan, accessible to all authorized personnel on approved devices, provides the advantage of enabling teams to identify potential issues that might halt production. Manufacturers can also benefit from further efficiency gains as a result of scheduling machine maintenance to ensure minimal downtime, aligning production with the validated process and eliminating duplicated tasks and rekeying because each employee is working from the same schedule. Managers benefit from being able to track progress in real time against the plan.
Increased visibility enables teams to match complex production processes against upcoming preventative maintenance and repairs. This is critical in the tightly controlled pharma sector where, as some of the major manufacturers are discovering to their cost, drugs can be rendered ineffective or dangerous if production falls behind schedule or is not properly audited.
As well as making existing operations more efficient, planning and scheduling software can also be used to perform a capacity analysis before production begins. As a number of vaccine trials advance to the final stage of testing, being able to prove your capacity ahead of an accelerated manufacturing program could make the difference in meeting the expectations of the global population awaiting a return to normality.
Spreadsheets or ERP systems will not be the platforms that provide the planning and scheduling for the Covid-19 vaccine or future pandemics. The key to ramping up vaccine production over the coming weeks and months will be having a firm, reliable basis of evidence for managers to make informed decisions, which will ultimately drive performance. This will avoid setbacks by saving time and reducing the likelihood of planning mistakes and delays that we can ill afford.
Only by putting the right technology in place can pharma manufacturers optimize resources, reduce lead times, and create a single plan of action to get the world back to some form of normality.
About the author
Rod Schregardus is biopharma manufacturing lead at The Access Group.