More Than Just Technology: A Holistic Approach To Pharma 4.0 Webinar Q&A
What is Pharma 4.0? It is a vision of a holistic company-wide transformation, which balances and combines: productivity, quality, and robustness based on a data-centric perspective.
During the "More Than Just Technology: A Holistic Approach To Pharma 4.0 Webinar", the presenter shared how it is possible to implement Pharma 4.0 to increase quality and productivity and decrease costs at the same time. Participants learned how the automation strategy becomes a user-driven program combining an equipment standardization program, the right global, company-wide infrastructure and the creation of a Global Data Model.
The webinar’s presenter, Petter Moree, shared how Pharma 4.0 and overall digitalization of pharmaceutical operations can only be defined in terms of performance and KPIs and how companies need a multi-disciplinary approach, where technology has to be a tool supporting and giving answers to business needs. Ultimately, at the end of the day, it is not about technology, but Change Management. People and Culture are far more important than technology.
Read below as the session speaker, Petter Moree responds to audience questions.
What does CPP and CQA means on the user & drivers slide?
CPP - Critical Process Parameter which has an impact on the CQA - Critical Quality Attribute. Often CQA is found in LIMS and CPP found in historians and infrastructure. It is possible to follow the CPP in real-time to ensure CQA are within the ranges.
What are the prospective of Pharma 4.0 /Industry 4.0 in supply chain management regards to reduced in forecast errors and its challenges if any ?
The most of operations consist of several unit operations internally or externally. Ability to manage them from an operational and scheduling point of view is critical for SCM and throughput, as well as the quality aspects to avoid warehouse expenses. Lab tests are having a significant financial impact and can be reduced and avoided if digitalization your organization is on a high level of maturity.
Sorry, What does R.U.T.H mean?
R - Recipe U - Doamin controller T - Time sync H - Historian Novartis definitions
Questions regarding R.U.T.H: Is it the data lake approach they are following here?
Yes, with the difference that it is also managing time-series data. Typically data lakes have unstructured data. In this case, it is structured with additional information about time, batch and equipment/ assets etc.
Outside of packaging, were do you see formal Overall Equipment Effectiveness (OEE) used in Pharma?
It has been seen both in Drug Substance and in Drug Product operations, e.g. pharmaceutical operations like tabletting and filling as well as for reactions or purifications of API. Sometimes I see adopted versions of OEE that better fit batch operations. The most important thing is to have the ability to drill down to root cause to take an appropriate action based on changes of KPIs.
Companies mentioned in the presentation, Novartis and J&J, are they OSI's service case?
OSIsoft have several hundred use cases from pharmaceutical companies
I have a question, as my knowledge on this topic is in using cyber physical systems in drug production, but where are you sourcing CPS terms?
The terms I use are coming from Digital Twins terminology. They are enabled by a process model and an equipment model.
I would like to know what are the different approaches between traditional validation and Validation 4.0?
Validation 4.0 is a term from ISPE Pharma 4.0 group.
People are talking about PAT for many years but not yet accepted or implement by pharma industry widely. In your opinion, what is the reason?
I have seen a significant increase of PAT in the last couple of years. There are many reasons for the slow uptake. In my opinion, there has been a balance between seeing the business benefit compared to a risk of testing an end product etc. Also, skillset, technology and price impact it, and yet the leadership has the most significant influence amongst all listed above!
What does IIoT and BMS means in the Energy Maagement Slide?
IIoT - Industrial Internet of Things. Companies use wireless sensors to measure temperature and it allows them to monitor both the sensor as well as the data coming from the sensor. BMS is a Building Management System which controls a building environment like temperature, humidity, pressure, etc.
How does Pharma 4.0 help in annual product review? is it possible to have cleanrooms qualification and invironment monitoring in this concept?
APR can be run automatically by generating reports and analysis when new data and batches are produced. The same functions can also be used for cleanrooms and other GMP areas. It is not part of APR but still using the same methods and tools.
About CPV, do you have a solution to automatically generate the report ?
I often see the usage of Statistica from Tibco connected to PI System using PI Integrators and LIMS systems etc
Is it accurate to say that all of the real-world solutions given as examples here (J&J, Lilly, Dr. Reddy's, etc.) are all home-grown indigenous solutions that are not commercially available to other manufacturers?
These are COTS solutions (commercial off the shelf) using standard tools configured to their processes and environment.
How do you think companies can use Cleanroom environment data in the context of Pharma 4.0 and Industry 4.0
To monitor these areas for specifications and alarms. Combine with other data for a better impact on quality and performance. I have seen examples from Roche, Lilly, and JnJ, which are all available on Osisoft.com.
Is there a single challenge that most companies face in getting started?
Yes, they aim too high initially using a waterfall approach, rather than learning by using an agile approach. They don't use available resources and SMEs. They think one need to establish something completely new. So they are focused more it is more on technology than business their business goals
Can you elaborate/expand on "DI by Design" please?
In general, it is about establishing a unified approach globally for all sites, plants, lines, and processes and their equipment management to ensure both data access, archive, context, security, audit trail, and interpretation..
You are mostly talking about horizontal supplier chain ... OSIsoft was bought by Aveva (would there not be there from the vertical supply chain much more potential?)
Let's wait and see what can be achived. I am very optimistic!
What about old machines, what can we do with them?
In many cases, data can be accessed using old protocols like Modbus or RS232 etc. Their data might be invaluable as service and spare parts could be hard to find, and condition-based maint would allow longer and better usage
Would you please summarize data integrity in essence?
In general it is about establish a unified approach globally for all sites, plants, lines and processes and their equipement to ensure both data access, archive, context, security, audit trail and interpreatation.
What is the integration of Engineering and Operational Data?
This is what a data infrastructure is enabling.
What should design firms bring to the table to help implement data integrity?
An ability to standardize the formats as well as the information which must be monitored. There are a lot of opportunities to prebuild digital twins and make machines accessible in a plug and produce ready environment
You’re talking about the classic approach for Validation (CSV) .. do you have any opinion on a modern approach (Computer software assurrance)?
Today, most CSV is done using the GAMP V-model, and the best success is to have a standardized approach where we see that ROI has been reached after less than 30% of the sites. I am not very familiar with the CSA and realize that vendors will have a different impact as this will be Agile using cloud technologies etc. Therefore it will have a different risk testing approach.
Given that Pharma 4.0 is going to be the future, how can I, an industrial pharmacy student from the Philippines, improve my skills to adapt to this?
Catch up on use cases on Pharma 4.0 as well as Industry 4.0 from the Pharma industry. I would also recommend that you join ISPE, which is a great organization, and they are leading Pharma 4.0, and besides this, they have s strong support for Young Professionals - JOIN that!
For information on joining ISPE, visit https://ispe.org/membership
In your opinion, what should be the first steps for a company to enter Pharma 4.0 smoothly or to make a smooth transition from a traditional to a Pharma 4.0 paradigm? And what is the expected level of effort required and key resources to have?
As mentioned, I think there are five elements to this, and it should start with the business objectives. What challenges are you trying to solve? I think one should be specific, and both have a global aim but, more importantly, have a focus on a well-defined project.
Can you please elaborate on predictive maintenance?
Is it possible to move from calendar-based maint to condition-based maintenance? Does it add additional value and a possibility to go to predictive maintenance? Can we see in advance when the equipment will need maintenance? Can we predict when this will happen etc.? It requires us to have data to train on aka look and to learn when and HOW this is happening. Often the limitation is the available model, meaning that we need several observations to generate a reliable and trustworthy predictive model. That is why condition-based maintenance is more straight forward.
I have a question on trending of Process Alarms require to perform at frequency of six month, are there any tools available for different manufacturing equipments?
This may be addressed through operational intelligence platforms designed to work with data residing in disparate equipment and systems. These systems can handle the process parameters, the process models, the failures and alarms and events as well as the digital twins.
I find to much reliance on cloud for everything what happens if it’s 1) hacked or 2) they stop your access for some reason like payment dispute take overs bankruptcy etc?
I agree with you; these are common comments regarding cloud technologies. I think that Cloud will be the future platform as it has also been for other industries like media, finance, etc. However, possibly a mixed hybrid with edge + on-premise + cloud is the MOST viable solution to handle such objections and trust?