What is Pharma 4.0? Vol.2

So now we are ready for Pharma 4.0, what does it look like?
Pharma 4.0 is today not a dream, there are now working examples in commercial pharmaceutical production that adopt many of these new concepts and technologies at production facilities which are qualified and validated according to the guidelines as established by ISPE’s GAMP5, (ISPE). The image in Figure 4 shows a real case study for new human-system integration using an Augmented Reality (AR) operator headset. The AR device is worn by the Operator and provides the strong controls and data capture of the MES at the same time being really useful for users who must work with their hands alongside the physical process.
Figure 4 shows the perspective of using the system from the operator eye view and how the system guides through a graphical visual aid that is overlaid ‘on reality’ through the headset to show physically on the equipment that the operator must install a specific change part. The description of the part and important settings and parameters that are required are displayed and integrated from the Electronic Batch Record (EBR) managed by the MES. Once the step is actually completed then the operator uses a gesture control to authorize the step is competed and the relevant records are automatically updated in the EBR. The next step is then displayed according to the correct sequence and overall completion status of the tasks at hand. Such use of human interfaces has already been shown to result in faster and more controlled processes, in the real life study then a 13% increase in the effective run time of the equipment was gained from a higher performance line change-over process.
 
In the shorter term, Pharma 4.0 concepts using AR and other techniques such as voice command integration will bring electronic systems even closer to humans who are still involved with the operations, at the same time then further automation and robotics will reduce the manual tasks to only those critical for decision making and management of the overall production and quality processes. Later as more information becomes integrated and available and complex decisions are automated using AI then we can start to really envisage and discuss how factories of the future will operate with an exceptionally high degree of autonomy and independence.
 
In summary, then as we start the Pharma 4.0 journey we do not yet know the final destinations that we will travel to, but it is certain to be highly exciting as we can already see from initial pilots and the possibilities of modern IT solutions in other industries and sectors. This is clearly an excellent time to be working in the industry as pharma becomes more responsive and open to change than ever before. As we have discussed then this fantastic future will not be possible if we continue to attempt to record, manage and extract information from data that is today locked away on paper records. It is now apparent that the end of the use of paper for critical data is fast approaching, as the data integrity expectations for regulators increases, the product demands for more flexible manufacturing such as QbD, personalized medicine, smaller batch sizes and continuous manufacturing grows. With the constant fast moving prevalence of technology in the consumer world then we have to ask ourselves, ‘if it is on paper, is it data?!
 

The sun is still rising on Pharma 4.0, will Asia be there first?
In the past then the pharma industry in Asia has lagged behind other industries in terms of technology capability, expertise and adoption. This is starting to impact the achievable productivity and quality regulation levels that can be attained but the region is starting to realise that it can be a leader in this new pharma area. Many companies in China, Japan, Singapore and Korea are already advanced in their digitization initiatives and across Asia even in less developed countries there is a greater awareness of the need to modernise using information technology than ever before.
It is time for Asian pharma to do what the region’s other manufacturing industries have excelled at for many decades; utilise the latest global technology and methods and drive forward to world beating levels of performance!


Bibliography
ISA. (2018). home - ISA. Retrieved from
https://www.isa.org/isa95/: https://www.isa.org/isa95/
ISPE, G. (n.d.). Retrieved from
https://ispe.org/publications/guidance-documents/gamp-5