The benefits of Industry 4.0 technologies, processes, and systems include improved productivity and efficiency, better flexibility and agility, and increased profitability. Industry 4.0 also improves the customer experience, including through more personalised and intelligent products.

Understanding and then contextualising these benefits is important, particularly in highly regulated industries like medical device, pharmaceutical, and biopharmaceutical manufacturing. Any investment you make in technology, improved manufacturing processes, or enhanced systems must also take into account compliance, quality, and patient safety.

It is essential that you get a return on investment too.

So, what are the benefits that Industry 4.0 technologies, processes, and systems can bring to your production lines and business? We have split them into four categories with a specific focus on high-speed, highly regulated production facilities in the life sciences sector:

• Manufacturing benefits of Industry 4.0
• Quality and compliance benefits of Industry 4.0
• Customer and patient benefits of Industry 4.0
• Operational Benefits of Industry 4.0

Manufacturing Benefits of Industry 4.0

Improved Productivity and Less Machine Downtime

In simple terms, Industry 4.0 technologies enable you to do more with less. In other words, increasing throughput while allocating your resources more cost-effectively and efficiently.

Your production lines will also experience less downtime because of deeper levels of integration, enhanced machine monitoring, and automated/semi-automated decision-making. OEE (Overall Equipment Effectiveness) will improve, too, as your facility moves closer to becoming an Industry 4.0 Smart Factory.

Improved Efficiency

Multiple areas of your production line will become more efficient as a result of Industry 4.0-related technologies. Some of these efficiencies are mentioned above – less machine downtime as well as the ability to make more products and make them faster.

Other examples of improved efficiency include faster batch changeovers, automatic track and trace processes, and automated reporting. NPIs (New Product Introductions) also become more efficient as does business decision-making.

Optimised Supply Chain Management and Security

With Industry 4.0 technologies, processes, and systems, you will have better visibility across your entire supply chain. Your supply chain will also become better connected, enabling real-time monitoring with enhanced communication and collaboration.

This can, for example, make it possible to identify bottlenecks and other supply chain problems before they have an impact on production line output. Having this advanced knowledge means you can take mitigation steps.

Your supply chain will also become more resilient and agile, improving your ability to respond to changing market conditions and customer demands.

Optimised Product, Production Line, and Factory Lifecycles with Digital Twins

Digital twin technologies capture data in the physical world to create a digital replica that updates in real-time. That replica could be a twin of a product, a production line in your facility, or your entire factory.

Having this digital twin allows you to optimise performance and efficiency and test different scenarios without impacting real-world output. You will also be able to identify areas of innovation and improvement.

Empowered People

With Industry 4.0 technologies, your people will have access to better data to give them enhanced oversight as well as the ability to take data-driven decisions.

Furthermore, you can eliminate the need for your people to work on repetitive tasks. With automation technologies and advanced workflows taking on repetitive tasks, your team can concentrate their efforts on value-adding tasks.

Increased Knowledge Sharing and Collaborative Working

Traditional manufacturing plants operate in silos. Individual facilities are silos as are individual machines within a facility. This results in minimal collaboration or knowledge sharing.

Industry 4.0 technologies allow your production lines, business processes, and departments to communicate regardless of location, time zone, platform, or any other factor. This enables, for example, knowledge learned by a sensor on a machine in one plant to be disseminated throughout your organisation.

Best of all, it is possible to do this automatically, i.e., machine-to-machine and system-to-system, without any human intervention. In other words, data from one sensor can instantly make an improvement across multiple production lines located anywhere in the world.

Flexibility and Agility

The benefits of Industry 4.0 also include enhanced flexibility and agility. For example, it is easier to scale production up or down in a Smart Factory. It is also easier to introduce new products to the production line as well as creating opportunities for one-off manufacturing runs, high-mix manufacturing, and more.

Quality and Compliance Benefits of Industry 4.0

Makes Compliance Easier

Complying with regulations doesn’t have to be a manual process in industries like pharmaceutical and medical device manufacturing. Instead, Industry 4.0 technologies make it possible to automate compliance, including track and trace, quality inspections, serialisation, data logging, and more.

Improved Product Quality

Industry 4.0 solutions can move quality functions from inspection rooms to the production line. This can mean real-time, in-line inspection with increased automation. The result is an inspection process that evolves from a go/no-go approach to one that is continuously measuring and analysing to improve processes and identify quality issues so they can be corrected before they get to a failure stage.

An increase in automation will also reduce human error in the quality function and automate the collection, transmission, and storage of data.

Customer and Patient Benefits of Industry 4.0

Better Customer Experience

Industry 4.0 also presents opportunities to improve the service you offer to customers and enhance the customer experience. For example, with automated track and trace capabilities, you can quickly resolve problems. In addition, you will have fewer issues with product availability, product quality will improve, and you can offer customers more choice (see the point about increased profitability below).

Personalised Products

Given the benefits they offer to patients, the medical device and pharmaceutical industries are moving closer to personalised products. For production facilities, this means mass customisation and increasingly smaller batch sizes down to as low as batch sizes of one.

With Industry 4.0 solutions, it is possible for manufacturers in the life sciences sector to personalise products within a high-speed mass production environment.

Intelligent Products, Particularly in the Medical Device Industry

Products across all industries are becoming more intelligent, including medical device products. Technologies like sensors, 5G, and the industrial internet of things (IIoT) make it possible to develop connected products that can share a wide range of information. This includes:

• Patient health data to enhance monitoring, treatment, and diagnosis
• Usage data to monitor the performance of the device
• Product data to help R&D teams develop improvements to existing products as well as new products

Intelligent products that are made possible with Industry 4.0 technologies can also perform multiple functions, including monitoring multiple health data points.

Operational Benefits of Industry 4.0

Reduces Costs

Becoming a Smart Factory does not happen overnight, and it won’t happen on its own. To achieve it, you need to invest, so there are upfront costs. However, the cost of manufacturing at your facilities will fall as a result of Industry 4.0 technologies.

Primary drivers for these reduced costs include:

• Better use of resources
• Faster manufacturing
• Less machine and production line downtime
• Fewer quality issues with products
• Less resource, material, and product waste
• Lower maintenance costs
• Lower overall operating costs
• Creation of innovation opportunities

Industry 4.0 technologies also give you a greater knowledge of the manufacturing process, supply chains, distribution chains, business performance, and even the products you manufacture. This creates opportunities to innovate, whether that is changing a business process, developing a new product, optimising a supply chain, improving OEE, and more.

Enhanced Potential for Innovation

The enhanced potential for innovation delivered by Industry 4.0 is a result of many of the points already highlighted:

• Digital twin technologies
• Knowledge sharing
• In-line real-time inspection processes
• Product personalisation and technologies that enable intelligent products
• Increased automation of repetitive workflows that enable staff to focus on value-adding tasks

Improved Decision-Making

Data is a key element of Industry 4.0 and smart manufacturing processes as machines and systems need to become more integrated so that data can be captured and used. This makes it possible to move to true data-driven decision-making in medical device and pharmaceutical manufacturing facilities. There is also the potential for machines to make decisions based on data, enhancing automation even further.

There is a range of benefits when you move to data-driven decision-making, including improving forecasting accuracy.

Higher Revenues

Many of the above points can result in higher revenues for your production facility. For example, by fully automating your production line and implementing other Industry 4.0 technologies, you could add a new shift with minimal staffing costs to meet an uptick in demand or compete for a new contract.

Increased Profitability

Increased profitability comes as a result of many of the points above, including higher revenues with reduced costs.

Furthermore, Industry 4.0 technologies enable you to produce higher quality, higher margin, and/or more innovative products. For example, Industry 4.0 technologies make it possible to offer customers personalised products while still using mass production methods to make those products.

Summary

The benefits of Industry 4.0 span manufacturing, business operations, compliance, quality, and the customer experience. As a result, the technologies and solutions that come under the Industry 4.0 umbrella are transforming manufacturing industries across the world.

While industries in the life sciences sector are generally behind other industries in terms of Industry 4.0 evolution, there are significant gains that can be achieved through careful planning.

Additionally, regulators are adapting to the realities of digital transformation and Industry 4.0, enhancing the potential even further. Other drivers are also accelerating the push towards Industry 4.0 solutions, including challenges in recruitment and the need to increase resiliency. With the benefits outlined above, it is also possible to get a healthy return on investment.

Staying competitive in a digitally transformed world is about continuous improvement with an Industry 4.0 focus.

The Project

The project outlined in this case study involved integrating the PAS-X MES platform into a customer’s production line. The customer is in the life sciences sector.

SL Controls’ parent company, NNIT, was the lead on the project. NNIT provided full support for the integration process, including scoping, design, deployment, and validation.

The first phase of the project involved defining the processes that would benefit most from storing electronic batch records. It was also important to define Master Batch Record (MBR) process flows and ensure MBR compliance with CFR Part 11.

An issue was identified at this point in the project, as the process would require the manual entering of data into the PAS-X MES. This had a number of negative implications, including the resources that would be required, the limitations it would put on the system, and the increased risk of human error that manual data entry brings.

To move the project forward and find an alternative solution to manual data entry, it was necessary to identify the production equipment that could be connected to the PAS-X MES platform. This would also involve determining the type of connection that would be needed and the required network infrastructure design.

This is where SL Controls got involved in the project, as we have significant expertise in equipment systems integration.

Objectives

There are five Operational Technology (OT) infrastructure levels in life sciences sector production facilities.

At SL Controls, our main expertise is in levels 0 to 2, i.e., designing and developing SCADA systems, developing data historians, batch performance tracking, integration of manufacturing equipment, etc.

We also have extensive expertise in the integration of manufacturing equipment with MES systems, as represented in the Plant Level. It was this expertise that was required, so SL Controls engineers joined the wider NNIT team.

Our expertise fitted in perfectly, as this stage of the project involved the integration of production equipment with the PAS-X MES platform.

What We Did

Our engineers worked with the customer’s automation engineers, as well as equipment vendors and our colleagues at NNIT, to identify the best methods for connecting the production equipment to the PAS-X MES.

We also proposed changes to the existing OT/IT infrastructure to facilitate data collection and batch information download from the new MES. We supported the customer’s IT and OT engineers in the implementation of these changes.

Our robust solution enabled data handling from the equipment on the production line to the PAS-X MES and vice versa.

Results

• With our solution, the PAS-X MES could be implemented with the risk of data errors significantly reduced as manual data entry was eliminated from the process.
• The solution is also robust enough to cope with the demands of a high-speed, high-volume, highly regulated production environment.
• The solution is compliant, too, as it satisfies the regulatory requirements of electronic batch records.
• We also provided a full end-to-end solution for the customer, utilising the expertise in both SL Controls and NNIT.

Sven Savic, SL Controls Systems Architect, said: “The acquisition of SL Controls by NNIT means the two companies now offer complementary skills that enhance the end-to-end level of service that we can offer. This unique and highly effective approach to project delivery was demonstrated in the successful delivery of this PAS-X MES implementation project.”

MES (manufacturing execution system) platforms are becoming increasingly indispensable tools in manufacturing facilities, including in the life sciences sector. There are many MES options available (including PAS-X), so it’s important to get the right advice and support to ensure the implementation of a solution that works for your organisation today and into the future.

In this blog, we are going to look at PAS-X, including what it is and why it could be the ideal MES solution for your pharmaceutical manufacturing facility.

First, though, a recap on the more generalised benefits of MES platforms. When properly specified, configured, integrated, and optimised, an MES platform will improve your production processes, increase automation by digitising manual workflows, and enable real-time monitoring and line management capabilities.

The benefits that result from these functions and capabilities include everything from improved allocation of resources to shorter production cycles to reduced time to market.

What is PAS-X?

PAS-X is an MES platform developed by German software developer Körber that controls, synchronises, and monitors production processes. It can be integrated and connected to all equipment, systems, and lines in modern manufacturing facilities. It can also be integrated with ERP platforms as well as more specialised systems, such as LIMS systems.

Crucially, PAS-X is suitable for all segments of the pharmaceutical industry, including pharmaceuticals, vaccines, and biotech. It is also suitable for all product types, including liquids and solids.

Why Choose PAS-X?

The main point to consider is the fact that PAS-X was designed specifically for the pharmaceutical manufacturing industry. It is also used by more than 50 percent of the 30 leading pharmaceutical and biopharmaceutical companies in the world. This point alone is not absolute, so it doesn’t mean PAS-X is the right option in all pharmaceutical facilities. However, it is tried, tested, and trusted in the pharma industry.

What about other factors to consider when looking at PAS-X? Here are the main points:

• PAS-X helps you achieve paperless manufacturing with the automation of manual and repetitive processes that are common in the pharmaceutical industry, particularly in relation to record-keeping.
• It meets the requirements of the FDA, European regulators, and regulators in other parts of the world. This includes the FDA’s 21 CFR Part II.
• It facilitates real-time monitoring, including remotely, of all data that your facility produces during production and packaging processes.
• PAS-X provides access to usable production data for everything from operational decision making to quality control to process optimisation
• Helps you digitalise production and documentation processes in your pharmaceutical manufacturing facilities, including compliant electronic batch records (EBRs).
• Enhances quality assurance efficiency by enabling review-by-exception, whereby an automated process checks batch reports. Only when a deviation is identified is the batch sent to the quality assurance team for further quality processing. This functionality, alongside the EBR capabilities of PAS-X, accelerates batch release processes.
• Enables fully digitised traceability of all batches and production processes.
• Helps to standardise processes across your production line.
• PAS-X has a modular structure so you can implement the elements that you need, adding new modules at later dates according to business requirements.
• It comes out of the box with preconfigured templates, accelerating implementation.

SL Controls – Your PAS-X Solutions Partner

At SL Controls, we have wide-ranging experience in PAS-X implementation, optimisation, and scaling projects, with specific expertise in integrating production line equipment with the PAS-X platform.

Our team can help with all stages of the project, including everything from creating a business case and defining the project scope to development, commissioning, and testing. In most situations, we’ll work with the preconfigured templates that come with PAS-X to customise your implementation while minimising timescales and project costs.

To find out more about PAS-X, to discuss a project you are planning, or to find out how we can help you overcome current challenges, please get in touch.

The regulated sector, including pharmaceutical and medical device manufacturers, is going through a period of transformational change. These changes are being driven by new product innovations, market pressures, the evolving regulatory landscape, and customer/end-user demands. MES solutions, powered by the platform Ignition, are enabling manufacturers to respond, including manufacturers in highly regulated industries.

SL Controls is a Gold Certified integration partner with Ignition. We have developed and deployed MES (Manufacturing Execution System) solutions for a range of clients, including pharmaceutical and medical device manufacturers.

Why MES Solutions are Important in the Pharma and MedTech Industries?

MES solutions optimise processes and line management, as well as providing you with optimisation tools that improve OEE. MES solutions also improve product quality and deliver cost and efficiency savings through:

• Improved resource allocation
• Real-time management of operations
• Improved maintenance processes
• Enhanced inventory control
• Smoother process changeovers
• More effective interoperability with other manufacturing systems
• Minimised product recalls
• Reduced time to market
• Improved use of data
• Elimination of human error, particularly in data handling
• Shorter production cycles

Why Choose the Ignition Platform as the MES Solution for Your Facility?

At SL Controls, our experienced engineers and system architects have spent considerable engineering hours investigating, working with, and developing solutions for a vast range of MES platforms, including the largest and most well-known.

We understand the opportunities that these systems present to pharmaceutical and medical device manufacturers, but we are also acutely aware of the challenges, limitations, and frustrations.

Ignition stands out from other MES platforms. With the Ignition platform and our expertise in regulated industries, we have delivered significant improvements and return on investment for our clients through MES solution deployments.

Some of the key features of Ignition that make it stand out include:

• It is a server-based, single-platform solution that includes everything from machine control to scheduling to data management to reporting. As it is server-based, the platform is always up-to-date, and it is easy to distribute.
• Everything is included in Ignition, simplifying the development process and minimising deployment timelines.
• It is easy to expand into other lines or facilities, or to scale according to business needs.
• It has a simple-to-use interface, and it is easy to operate, with a short and shallow learning curve.
• Ignition is more cost-effective than other platforms, and it operates a flexible licensing model that facilitates innovation and makes it easier and less costly to scale. Specifically, it operates a pricing model with unlimited licensing and unlimited free tags and runtime clients.

While it may not be as well-known as other MES platforms, Ignition is used by tens of thousands of facilities across a range of sectors in 75 countries.

Benefits of SL Controls’ Ignition-Based MES Solutions

• Manufacturing efficiency improvements
• Reduce downtime
• Minimise waste
• Capture, monitor, analyse, and control manufacturing data
• Optimise quality control processes and eliminate product defects
• Enhance high-level oversight of entire operations
• Integrate production (OT) with ERP and other business systems (IT)
• Reduce OT and IT costs
• Improve the utilisation of assets and OEE through downtime tracking and visualisations that include OEE calculations
• Identify production trends and manage processes and inventory in real-time
• Track raw materials through to finished state with real-time oversight
• Suitable for applications that range from single lines to enterprise-wide
• Highly flexible and customisable. For example, if you have an existing SCADA system, you can choose to use Ignition for MES or you can use Ignition to expand your SCADA system into an MES. Modules can also be easily added and removed.

Your Ignition and MES Integration Partner

At SL Controls, we have engineers on our team that is fully trained on the Ignition platform. We also have direct experience developing and deploying MES solutions for clients in regulated sectors. In addition, we are continuing to expand this team of Ignition specialists as demand for MES solutions increases in the industries that we serve.

The adoption of MES solutions is a key priority for improvement-minded, forward-thinking pharmaceutical and medical device manufacturers. An SL Controls developed, deployed, and supported MES solution, powered by Ignition, will help your business achieve its modernisation objectives.

Microsoft Cloud for Manufacturing is on its way. It was announced last year as one of several new industry clouds that Microsoft is developing, and it is currently in preview mode. What can manufacturers in the pharmaceutical, medical device, and technologies industries expect from this new Microsoft solution?

For us at SL Controls, Microsoft’s Azure cloud has been our platform of choice for some time now. We remain technology agnostic and have skills and capabilities across all leading cloud computing platforms, but we lean towards the Microsoft suite of services whenever it is appropriate to do so.

With this experience of delivering Industry 4.0 and digital transformation solutions using Azure and other Microsoft technologies, we have been watching the development of Microsoft Cloud for Manufacturing with interest since it was first announced.

What is Microsoft Cloud for Manufacturing?

Let’s start with what it is not – Microsoft Cloud for Manufacturing is not an alternative to the Azure platform, nor is it a unique instance of Azure. Like the other industry clouds in its suite of solutions, Microsoft Cloud for Manufacturing includes Azure and other Microsoft products, but they are extended and refined to have more relevancy for the manufacturing industry.

For example, Microsoft Cloud for Manufacturing will have APIs, workflows, templates, and standards designed specifically with manufacturers in mind. The aim is to make it quicker, easier, and more cost-effective for manufacturers to implement Industry 4.0-related solutions.

What You Can Do with Microsoft Cloud for Manufacturing?

The capabilities of the Microsoft Azure platform make it possible to implement a vast range of solutions needed by the life sciences and technologies industries. Microsoft is highlighting five main areas in this preview stage of Cloud for Manufacturing:

• Agile factory of the future – improving IT/OT security, operational visibility, and OEE, as well as utilising machine learning to improve productivity, quality, safety, etc
• Supply chain resilience – optimising the supply chain and improving supply chain planning and visibility
• Digital innovation – using digital twin technologies to improve everything from product development and product quality to machine downtime and output
• Workforce transformation – connecting workers and improving collaboration, particularly between those on the factory floor and those in the office, as well as improving training and skills development
• Customer engagement – improving customer service and the sales process, particularly in relation to demand management

These five areas are crucial, but our experience at SL Controls tells us the above list is only part of what is possible in the Industry 4.0 space with the Microsoft technologies that are set to be included in Cloud for Manufacturing.

Accelerating Change in Pharma and MedTech Manufacturing

With Microsoft Cloud for Manufacturing, manufacturers will continue to have access to proven, enterprise-ready equipment systems integration and automation platforms that will transform operations. At SL Controls, we have the skills and experience to customise Cloud for Manufacturing to deliver fast, tangible results for companies in highly regulated industries.

With our capabilities and the suite of Microsoft tools packaged under the Cloud for Manufacturing umbrella, your entire operation will become more agile, with end-to-end visibility, an empowered workforce, and enhanced sustainability. Data-driven decisions will become the norm, you will be more competitive, and you’ll become more resilient even in the most turbulent of markets.

Finally, while Microsoft Cloud for Manufacturing isn’t publicly available yet, the Microsoft products that will be a part of it are well-established. Examples include:

• Microsoft Azure
• Dynamics 365
• HoloLens 2
• Microsoft 365
• Microsoft Teams
• Microsoft Power Platform
• Microsoft AI
• Microsoft Cloud for Sustainability

At SL Controls, our architects and engineers can also integrate systems and platforms from other vendors.

We are looking forward to the public introduction of Microsoft Cloud for Manufacturing as we continue to use Azure and other Microsoft technologies to deliver advanced systems integration and smart manufacturing solutions for our clients.

There are a number of challenges facing the pharmaceutical and medical device manufacturing industries. Those challenges include labour shortages and developing supply chain resilience. There is also an increasing requirement to become more agile, where production facilities can react faster to changing demands and expectations.

Pharmaceutical and medical device companies also have to deal with changes in medical device regulations, such as the recently introduced EU MDR, while there are always pressures to improve productivity and profitability.

Automation technologies are a crucial part of the solutions to these challenges. This includes everything from robotic process automation (RPA) solutions to advanced equipment systems integration to the development of future-proof cloud to edge technology architectures.

It isn’t just about challenges, either, as there are also opportunities that become available to manufacturers through advanced automation solutions.

Below are some of the ways automation and other Industry 4.0 technologies are helping pharmaceutical and medical device manufacturers address current challenges and take advantage of the opportunities that exist

Improve Current Processes Without Increasing the Existing Footprint

Doing more with less is often the objective of pharmaceutical and medical device manufacturers. Automation and other Industry 4.0 solutions make this possible.

By integrating equipment and systems throughout all stages of the production process, making better use of data, and utilising advanced, hybrid cloud technologies, it is possible to optimise existing manufacturing processes within existing footprints and with a reduced labour requirement.

Minimise New Product Introduction (NPI) Timescales

The experience of Covid-19 is likely to have changed the pharma and MedTech industries considerably and irrevocably. An example of a driver of these changes is also one of the biggest success stories of the pandemic – the introduction of vaccines. What we saw was the industry developing, testing, obtaining regulatory approval, and moving to at-scale manufacturing at a pace never seen before.

This experience demonstrated what is possible, and it presents potentially positive commercial opportunities for life sciences sector companies.

Not every new medical device product or drug will benefit from such rapid development and commercialisation, but where they are applicable, automation technologies and solutions will play a key role.

Minimising Engineering Time

Automation can reduce engineering time, enabling the rapid deployment of solutions and processes that deliver immediate production and business benefits.

An example is the use of cloud technologies to develop new software solutions for pharmaceutical and medical device manufacturers. When cloud platforms like Microsoft Azure are used, the solutions become repeatable on multiple deployments, automating the process of rolling out the solution to additional lines and facilities.

Digital Twin Technologies Enhancing Agility and Flexibility

Digital twin technologies are suitable for a range of applications in modern pharmaceutical and medical device manufacturing facilities. This includes the implementation of a preventative maintenance approach, where maintenance work is completed based on real-world requirements and predicted component failures rather than pre-determined timescales and unexpected downtime caused by actual failures.

Digital twin technologies can also be used to enhance agility and flexibility in production environments. For example, production processes, machines, and equipment can be replicated digitally in the cloud, so engineers can work on modified or expanded designs. Those designs can then be validated in the virtual simulation, enabling rapid deployment when the amended operations are required.

The Future of Automation

Automation has been important in manufacturing for many decades now, but we are entering a new era with the availability and capabilities of Industry 4.0 technologies. This includes everything from the Industrial Internet of Things (IIoT) to smart manufacturing methodologies to digital transformation strategies.

Automation isn’t the only solution to the challenges faced by manufacturers in regulated industries. However, it is the central component in many and a crucial consideration in most.

Good Distribution Practice (GDP) is a quality system for warehouses and distribution centres that process medicines. Historically, GDP only covered the movement of finished products from manufacturing sites to wholesalers, retailers, and patients. These parts of the supply chain are still covered by GDP, but the guidelines are now applicable throughout the whole supply chain, from raw materials to the finished product and everything in between.

The EU added this enhanced GDP requirement to its guidelines in 2013 because of increased globalisation, the sensitivity of certain therapeutic drug molecules, and the stricter controls that are now required to maintain the quality and integrity of medicinal products.

Failure to adhere to the guidelines at any point in the supply chain, including all intermediate points of storage and transport, can have a serious impact on the quality of the product.

Is Good Distribution Practice Essential?

For companies involved in sourcing, storing, and transporting APIs and other ingredients for pharmaceutical manufacturing, the adoption of GDP is a crucial tool to ensure patient safety, product integrity, and product availability. It is also essential for similar reasons for companies involved in the distribution of finished products to the end-user.

Here is how EU regulators define GDP in the guidelines:

“These Guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these Guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products.”

The guidance also says that wholesale distributors must comply with GDP to obtain wholesale distribution authorisation. Wholesale distribution authorisation is required for the wholesale distribution of medicinal products in the EU.

Why Thermal Compliance is Relevant to GDP

Product deterioration is one of the main challenges that pharmaceutical companies face when ensuring patient safety and product quality. As deterioration is significantly impacted by temperature and humidity, the following two areas need to be addressed to maintain products in an optimal condition during storage and distribution:

1. Ensuring storage conditions follow product labelling requirements (for example, not storing above 25°C)
2. Providing documented evidence that demonstrates consistent adherence to the storage requirements listed on product labels

By following GDP, the above can be achieved through:

• Documented temperature mapping studies (empty/full/seasonal/challenge conditions)
• Documentation that temperature monitoring placement is determined by a risk assessment of high/low thermal risks as identified through temperature mapping studies
• Continuous temperature monitoring system with timely alerts of temperature deviations
• Calibration of temperature monitoring systems
• Ensuring compliance with standards on temperature/humidity mapping and monitoring, shipper route qualifications, calibration, and validation

GDP Compliance Situations that Companies May Face

Pre-Audit Assessment

Businesses should always be ready for inspection. However, a letter from regulators announcing a date for inspection can cause high levels of stress and disruption due to a lack of readiness. To ensure your organisation is better prepared, you should conduct a pre-audit assessment to understand your level of conformance with EU guidelines, including GDP guidelines.

If You Have an Existing Wholesale Licence

Audits are part of holding a licence to store and distribute medicines in the EU. You might face a situation where an audit from a regulatory authority, such as the HPRA in Ireland, raises issues with your level of compliance.

A common example of such an issue is the placement of continuous monitoring probes. In this example, a thermal profile should be created through seasonal temperature mapping, with the location of monitoring probes determined by that profile.

New Application for Wholesale Licence

If you are preparing to make a wholesale licence application to a regulatory authority, you will need to ensure compliance with GDP guidelines. This includes guidance on thermal compliance. For example, you will need to:

• Assess the capability of your facility to store medicinal products within the required range of temperatures
• Create a thermal compliance strategy
• Establish an effective thermal monitoring system
• Validate the thermal monitoring system and compliance strategy
• Ensure the ongoing integrity of the system through annual calibration and a preventative maintenance approach

Here is an example of a typical strategy for ensuring compliance:

Product Quality, Patient Safety, and Compliance

GDP is rightly looked at as a compliance issue as there are guidelines and regulations that need to be followed. However, it is also important to remember that compliance is only one of the benefits of GDP for your wholesale or distribution operation.

Adhering to GDP helps you maintain product quality standards, enhancing the service you offer to clients. It also helps you meet your responsibilities in relation to patient safety.

In other words, adhering to GDP has commercial as well as regulatory benefits.

The past 12+ months has seen supply chains face considerable disruption – disruption that has altered perspectives and priorities. While Covid-19 is not the only reason for these disruptions, it is a significant factor. The pandemic isn’t over yet, either, bringing further uncertainty.

While there are uncertainties, there are also opportunities in warehouse and supply chain management as we look to 2022 and beyond. Those opportunities are driven by technologies, as well as by changes in consumer behaviour.

Bringing that all together, we’ve put together a list of the top seven warehouse management and supply chain trends for 2022.

1. Supply Chain Resilience

As mentioned in the opening sentence, it has been a tough period for supply chain management. The reasons are varied and include material and labour shortages, increased costs, and shipping challenges. Those things individually probably won’t last forever, but the more general experience of disruption has shone a spotlight on the issue of supply chain resilience.

Establishing supply chain resilience requires a broad strategy, with agility being an essential component. With agility built into your supply chain, you can pivot when disruption occurs. You may even be able to pivot before the disruption has an impact.

However, for your supply chain to become more agile, you need data. Data increases visibility and helps with decision-making, both of which are required for an agile approach. Therefore, we can expect more companies to develop supply chain resilience throughout 2022 and beyond by creating digital supply chains that maximise integration at all points.

2. Artificial Intelligence

AI would make the list of top trends for 2022 in most industries and sectors, and it is going to be important in warehouse and supply chain management too. It is a technology that is becoming more advanced, and with that improvement comes greater impact and familiarity.

In warehouse and supply chain management, AI and machine learning can help with data analysis and decision-making, while also optimising processes and operational efficiency.

3. Robotic Automation

Robotic automation has been a growing trend over recent years, and this growth is set to continue through 2022 as companies seek to improve productivity and deal with warehousing and supply chain challenges.

In particular, we will see a movement away from fixed automation systems to smaller mobile robots. 5G connectivity and machine vision systems will also play increasingly important roles, and cobots will become more common in warehousing and distribution operations.

4. Cloud Technologies

The rate of adoption of cloud technologies is increasing as companies make progress on their digital transformation strategies. Advances in hybrid cloud solutions is one of the reasons for this, where cloud architectures now include cloud, multi-cloud, on-prem, and edge elements.

Improving the performance of IT and operational technologies is an important motivating factor for migrating to the cloud, as is reducing IT infrastructure and maintenance costs. A move to cloud technologies also helps to eliminate the data silos that still exist in many warehousing and supply chain operations.

5. Big Data

Data is another point on this list that is not exclusive to warehousing or supply chain management, but its importance cannot be understated. There is an increasing reliance on data as companies improve collection, storage, and processing. This leads to the production of useful data that can be quickly digested in attractive data visualisations.

Good access to data also makes it possible for warehousing and supply chain operations to start using predictive analytics.

6. The Introduction of the Blockchain

Blockchain technologies in warehousing and supply chain management are in their infancy, but they have the potential to be a substantial growth area. Blockchain technologies can also increase transparency in warehousing and supply chain operations, while also reducing risks and streamlining processes. We are still at the start of this journey, but it is a trend to look out for.

7. Creating Sustainable Operations

Warehousing and supply chain operations are increasingly adopting technologies and strategies to make their operations more sustainable. From introducing electric vehicles in warehouses to minimising the environmental footprint of supply chains, sustainability will be a hot topic for some time to come.

Advancing the Sector

All the trends on this list will help warehousing and supply chain operations improve throughout 2022, becoming more competitive, productive, and efficient, while also increasing profitability. It is a period of transformation, and that brings challenges, but there are exciting opportunities too.

[full_width padding=”10px 0 10px 0″]Over the course of 2021, the SL Controls team has published blogs on a range of topics related to Industry 4.0, the Smart Factory, and equipment systems integration. Here are some of our top posts of the year.[/full_width]

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5 Crucial Smart Manufacturing and Industry 4.0 Focus Topics for 2022

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[full_width padding=”0 0 10px 0″]At this time of year, it is common to see articles looking at the trends that will be important over the coming 12 months, particularly in relation to technologies. We even produce these articles ourselves at SL Controls. However, it is also important to look at smart manufacturing and Industry 4.0 more broadly to assess the challenges and opportunities that lie ahead as we move into 2022.

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Transitioning to Smart Manufacturing – A Practical and Cost-Effective Approach

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[full_width padding=”0 0 10px 0″]The business case for implementing smart factory technologies is compelling, with tangible improvements in revenue, output, quality, and safety, alongside reduced costs. It is not surprising, therefore, that smart manufacturing technologies are becoming an increasingly important competition driver.

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The Essential Steps in Your Smart Factory Evolution

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[full_width padding=”0 0 10px 0″]Moving your business closer to becoming a Smart Factory is widely regarded as essential to continuing competitiveness and profitability. Driving efficiency savings, making productivity gains, dealing with skills shortages – these are just some of the challenges that manufacturers face, all of which can be considerably mitigated with Smart Factory solutions.

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Bridging The Machine To Cloud Gap For Life Sciences And Technologies Manufacturers

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[full_width padding=”0 0 10px 0″]Industry 4.0 as a concept provides manufacturers with impressive benefits and wide-ranging opportunities. The technologies and solutions that fall under the Industry 4.0 umbrella also help mitigate the existing and emerging business risks faced by those in the pharmaceutical, medical device, and electronics manufacturing industries. That said, Industry 4.0 is a data-driven industrial revolution. Therefore, significant challenges exist when you begin to connect the concept of Industry 4.0 with the realities of existing manufacturing systems, processes, and operations.

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Build Once, Deploy Multiple Times in Seconds – Cloud-Based Solutions for Pharma & MedTech Manufacturers

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[full_width padding=”0 0 10px 0″]For pharmaceutical and medical device manufacturers, repeatability is a primary goal when developing new manufacturing software solutions. The concept is simple – you select a facility or production line for the initial project, creating a software solution to deliver on your manufacturing and business objectives. Once you have that operational and delivering results, you can then look at deploying the solution in additional facilities and production lines.

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Qualification Of Cloud Infrastructure And SaaS To Demonstrate Regulatory Compliance

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[full_width padding=”0 0 10px 0″]Cloud infrastructure solutions, as well as Software as a Service (SaaS), Infrastructure as a Service (IaaS), and Platform as a Service (PaaS) solutions, offer significant benefits to manufacturers in the pharmaceutical and medical device industries. Cloud-based solutions still need to be validated, however, just like your on-premises software.

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The Cybersecurity Risks Created by Industry 4.0’s Increased Attack Surface

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[full_width padding=”0 0 10px 0″]Businesses in all industries face an ever-increasing range of cybersecurity risks. This includes companies in the manufacturing sector. When you look at regulated industries such as pharmaceutical and medical device manufacturing, where patient safety is a top priority, cybersecurity risk levels can be even higher.

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Taking a Holistic Approach to Cybersecurity in the Transition to Becoming a Smart Factory

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[full_width padding=”0 0 10px 0″]In a recent blog, we highlighted the cybersecurity risks that are created by the increasing attack surface in manufacturing organisations. As a quick recap, as you integrate systems, platforms, and equipment, and as you connect elements of your operation to the cloud, the potential attack surface in your organisation expands, exposing you to higher cybersecurity risks. In our previous blog, we also highlighted the key to mitigating these risks – taking a holistic approach to cybersecurity as you transition to a Smart Factory.

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An Overview of the Industry 4.0 Cybersecurity Risk Mitigation Process

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[full_width padding=”0 0 10px 0″]In previous blogs in this series, we looked at one of the unintended consequences of implementing Industry 4.0 technologies and processes – the increased attack surface. In other words, the more equipment you connect, the larger the target for would-be attackers. We also looked at the challenges of dealing with this Industry 4.0 cybersecurity issue, and we outlined the main best practices. In this final blog in the series, we outline the Industry 4.0 cybersecurity risk mitigation process. This process will help you overcome the challenges of cybersecurity and protect that ever-growing attack surface.

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How Good Distribution Practice (GDP) differs from Good Manufacturing Practice (GMP)

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[full_width padding=”0 0 10px 0″]Good distribution practice (GDP) and good manufacturing practice (GMP) are quality standards and guidelines that have the same ultimate objective – to ensure medical device and pharmaceutical products are safe, meet their intended use, and comply with regulations.GMP focuses on manufacturing processes, while GDP covers distribution activities. There are crossovers between both manufacturing and distribution, however. So, what are the main differences between GDP and GMP?

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