Increase the efficiency of your pharmaceutical production with intelligent MBR design

In the highly regulated pharmaceutical industry, the design of the Master Batch Record (MBR) plays a pivotal role. It contains all specific production steps and instructions, ensuring the consistency and quality of a particular pharmaceutical product or batch. 

A well thought-out MBR design is not only essential for compliance with legal regulations and quality standards, but also for the optimization of operational, reliably reproducible processes and the minimization of errors due to human influence in the process. In this article, we highlight the importance of MBR design and explain how good MBR design contributes to quality assurance, compliance and efficiency improvements.

Highlights:

• How a good MBR design contributes to compliance and quality assurance
• Reproducibility and process optimization thanks to intelligent MBR design
• Understanding all production processes precisely

Fast market launch, safe production and compliance with GMP (Good Manufacturing Practices): Pharmaceutical producers are confronted with a multitude of complex requirements. Conformity or compliance are also critical aspects in the pharmaceutical industry. Every production step must be documented and traceable. A well-designed MBR ensures exactly this: all necessary data is recorded and stored correctly. This is particularly important for compliance with guidelines such as Good Manufacturing Practices (GMP). Philipp Klaesle, Vice President MES & Process Management Consulting, in the Körber Business Area Pharma: "The MBR lists all work steps during the production of pharmaceutical products and specifies requirements for documentation and signatures." This ensures compliance with guidelines and all steps can be quickly and easily traced digitally. In contrast to time-consuming and error-prone work on paper, MBR saves valuable time and money. Fewer human resources are required and troubleshooting can be carried out more efficiently. This avoids the need to dispose of entire batches.

Quality assurance through MBR design

According to Michael Krug, Team Lead MBR Consulting, Körber Business Area Pharma, another decisive advantage of a well thought-out MBR design is quality assurance, as the MBR not only documents the production itself, but also records all process data. Thanks to digitalization, deviations from the target process can be detected and corrected immediately. This makes the work of the compliance and quality assurance teams much easier, as they can concentrate on the relevant deviations instead of manually checking all production data.

Reproducibility and error reduction

The ability to make processes reproducible and minimize human error is a major advantage of digital MBR design. Philipp Klaesle compares the MBR to a recipe in a cookbook: "I can bake a perfect cake ten times with one recipe. If I bake the cake and document exactly how I do it, then anyone else can make this excellent cake in exactly the same way - it's similar with an executed batch record." This standardization and documentation ensures that every production process is consistent and error-free. The digitization of the MBR also makes it possible to identify and rectify deviations immediately, which further reduces the error rate. However, this also means that all processes and production peculiarities on site must be taken into account. This is why the consultants from Körber get a precise picture of all processes in advance: it also includes local conditions such as the positioning of the trolleys, which cannot be overcome with full containers, operating buttons that are outside a clean room or other eventualities.

Optimization of processes

With the introduction of a Manufacturing Execution System (MES) and the associated process analyses, there are opportunities for both the optimization and automation of processes. This enables a more efficient use of resources and a faster market launch of products. A good MBR design then helps to standardize and document the processes. In addition, digital documentation allows all process data to be stored and used later for process optimization and business/production analyses.

Faster time to market thanks to optimized processes

At Körber, we don't just create the most efficient MBR possible. For us, close cooperation and partnership is a particularly important and promising aspect of our work. 

• Our teams are diverse, with a wide range of backgrounds and skills - that is our strength
• We have mastered the implementation of MBR design in the common MES
• We want to understand all of our customers' workflows and processes precisely - so the MBR design meets the specific requirements and circumstances and delivers optimum results
• We carry out a thorough process analysis and are directly involved on site at the customer's premises
• We take our time, look at all critical points and scrutinize existing processes
• We value a trusting partnership with our customers

Conclusion

A well thought-out MBR design is essential for the pharmaceutical industry to ensure compliance, safeguard quality and optimize processes. This approach enables pharmaceutical companies to bring their products to market faster and more safely while meeting the high regulatory requirements. The digitalization and automation of production processes through an MES and an efficient MBR design help to minimize human error and increase efficiency. At Körber, we rely on close collaboration with our customers and a thorough understanding of their specific processes to provide customized solutions that fit our customers perfectly.

Do you have any questions? We look forward to hearing from you!

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