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Large and medium-sized Asian pharma manufacturers are constantly under pressure to produce high quality products on time. Economic fluctuations as well as compliance with strict legal requirements are causing manufacturers to face complex situations every day. Trying to minimize costs and make profits while maintaining the competitiveness is indeed very challenging. The best and utmost solution to increase efficiency at reduced costs is to digitize production processes by introducing a Manufacturing Execution System (MES) that will help address various issues at production level.
Pharma and biotech companies gain MES benefits from high quality control, reduced downtime and shop floor transparency as every manufacturing activity can be easily traced. As a result, the quality of production can be significantly improved. With the help of MES, it is easy to ensure that the manufactured products are produced as planned in a timely manner. Costs are kept down with efficient and cost-effective production, significantly improving performance of the organization and achieving profitable outcomes.
Last but not least, when deciding to start an MES project, it is necessary to understand the benefits in all end-to-end manufacturing processes. Conducting a business benefit analysis can help identify the added values so that the investment for improving the efficiency of production processes will actually pay off.
The evolution of modern, IT-based production management systems
Since the early 1990s,many leading pharmaceutical and biotech manufacturers in Europe and the US have begun to feel the pain of managing day-to-day operations. They are challenged by a variety of tasks, analyses and the lack of effective solutions to manage and maintain all the requirements demanded by regulatory authorities. While some challenges are associated with increasing efficiency and productivity, others are the result of inconsistencies in internal production processes and lack of clear procedures. This often results in data integrity expectations not being met and a major setback for the organization. Another major challenge was the lack of effective interaction between departments, systems and transparency regarding important performance and quality indicators, directly affecting competitiveness in terms of product costs and quality.
These challenges led to a new category of manufacturing software for the pharmaceutical industry: Manufacturing Execution Systems (MES). This software promises accurate, real-time data capturing to improve decision-making processes and the resulting actions that drive customer service improvements and decrease manufacturing cycle times – helping companies maintain a competitive advantage position in the market.
What is a Manufacturing Execution System (MES)?
An MES is often viewed as the central IT system of the pharma manufacturing shop floor. All production-related recipes, parameters and procedures are stored in the MES. The system also provides process monitoring, documentation, simple and fast integration of equipment and data analysis as well as operator guidance. In layman’s terms, MES is the brain of production.
Before getting started with MES, many pharma companies ask themselves questions such as:
- What benefits do we gain?
- What do we lose if we don’t implement an MES?
- How do we choose the right MES supplier?
There is another key strategy aspect which causes confusion in the minds of organizations looking to embark on their first MES project. The question is whether to operate manufacturing execution on an existing SAP or to look for a specialized MES solution to manage the high complexity in production processes.
Based on our experience, we draw the conclusion for the pharma and biotech industry that environments with complex dynamic processes are better supported by an MES system. Reasons include a simple user interface, the ability to effectively manage complex processes, specific automation interfaces and requirements regarding availability and independence of the shop floor system.
Business benefits of MES
Over the past decades, we have learnt that virtually every pharma manufacturing operation – regardless of size, complexity and type of product –can benefit from adopting an integrated MES solution. According to a study by Werum among major pharma manufacturers, many Asian pharmaceutical companies – early adopters of MES systems – stated the following benefits:
Benefit 1: Digitize & automate manufacturing processes
MES helps you manage and maintain your processes more efficiently. The high right-first-time factor ensures that there is no material mix-up and that the right quantity of the correct material is charged to the process via barcode verification. The digitization of processes also enables production and quality assurance teams to work on the batch records in parallel. The MES system makes this possible by significantly improving operation visibility and providing an accurate real-time data access.
Benefit 2: Safeguard regulatory compliance
We all agree that data integrity is extremely important – especially when working in highly regulated industries. The ALCOA principle is an essential part of Good Manufacturing Practices (GMPs) where data must be attributable, legible (permanent), contemporaneous, original and accurate.
Managing these compliance requirements with a paperless manufacturing system ensures 100% adherence to ALCOA in batch records and equipment logbooks. It helps improve the justification quality for events and exceptions that often go unnoticed on paper. MES also helps reduce errors associated with Good Documentation Practice (GDP), missing entries and calculation errors which are frequently observed on paper batch recording.
Benefit 3: Improve manufacturing efficiency & productivity
It’s quite amazing to see the positive impact an MES system brings to the manufacturing shop floor. Typically, improvements are experienced in all areas. Here are some examples from our study:
- Increased space utilization
- Increased material retrieval time in the warehouse operation
- A high right-first-time factor eliminating the risk of material mix-up and verifier signatures traditionally required in weighing & dispensing
- Contemporaneous batch recording and automatic equipment logbooks in manufacturing and packaging areas assisting the operator to focus on value added activities with direct impact to product quality
- Batch record releases based on exceptions helping to speed up review and release times
Moreover, an MES system also provides flexibility and scalability to contract manufacturers with large number of stock keeping units (SKUs). We will be further exploring this aspect in one of our future blog posts.
When taking a holistic view at the manufacturing shop floor operating on MES systems, we observed that pharma manufacturers can save costs and efforts and avoid risk while also achieving a faster time-to-market.
Benefit 4: Advance data analytics
We believe that data is going to emerge as a fundamental competitive advantage. Combined with our knowledge and expertise in the pharmaceutical and biotech industries, we are able to harness data, analytics and design providing a clear path for our customers to improve quality and performance. MES is a primary platform which stores all manufacturing-related data. Our Enterprise Manufacturing Intelligence (EMI) solutions use the data that is inside the organization and accurately understand the data patterns which our customers can exploit.
Case study: API yield increase in high value biotech
Earlier we started a pilot in the biotech space. A leading multinational pharma and life sciences company from Germany has commissioned Werum to integrate a prediction model for the optimal time to extract an API into a biopharmaceutical manufacturing process. The API is separated from undesired secondary components by means of an extraction process using chromatography columns in the downstream phase. Until now, this had been done by an experienced employee who decided on the start and end times of the extraction based on IPC data. From the history of this chromatography data, Werum generates a prediction model based on neural networks. The model predicts the optimal time to extract the API and will be simultaneously integrated into the process. The benefits for the pharma company are invaluable: through the process optimization, they can increase their product yield by about one percent of additional API!
Benefit 5: Enable Pharma 4.0
Whether or not they are already using MES – most companies are not fully aware of what state-of-the-art systems can do. Most MES currently on the market can manage today’s factory. Most can also handle some aspects of vertical and horizontal integration, mobile, cloud and analytics. However, for the Pharma 4.0 factory of the future, the specific capabilities for scaling and shifting to coordinate autonomous, decentralized networks of automated equipment collaborating with dynamic activity are of utmost importance. In this context, in-depth study is required to distinguish future-ready MES from others. The ability of some systems to handle not only operations but also analyses and coordination activities across the supply chain is remarkable.
What you lose if you don’t implement MES
Most companies which still do not have an MES in place might not realize what they are losing each day when they are delaying MES deployment. They rather wait for others to start the project first and see the outcome of it. Without MES, a company is always vulnerable to face issues with data integrity, material mix-up and product quality. Moreover, there is a risk to miss opportunities to grow and expand. No standardization is feasible without a proper system.
Aside from all the aforementioned benefits, it is even more critical that companies will be losing the opportunity to drive their digital advancement. MES is the foundation that helps manufacturers pave their way towards Pharma 4.0 and drive digitization within their organization.
How to select the right MES supplier
Choosing an MES vendor is a complex process which requires expertise and hard work before making a decision. It is recommended to select a highly experienced vendor with an excellent track record of success. This ensures a fast and effective project delivery using best practices from top pharma and biotech companies. An MES system is a critical IT solution that needs to last for decades and when a company chooses to work with a given MES supplier, it enters a long-term strategic partnership.