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How Generic Master Batch Records (GMBRs) Can Improve Packaging Efficiency

In the pharmaceutical and manufacturing industries, Generic Master Batch Records (GMBRs) are increasingly being used to improve packaging efficiency. GMBRs are a type of master batch record that groups together similar workflows, reducing the number of individual MBRs required. This can lead to significant savings in time and resources, as well as improved compliance and traceability.

The Need for GMBRs in Packaging

Packaging is a complex and challenging process, especially in the pharmaceutical industry. There are often many different product versions, each with its own specific requirements. This can lead to a proliferation of MBRs, which can be difficult to manage and maintain.

GMBRs can help to address this challenge by grouping together similar workflows. This reduces the number of MBRs required, making it easier to manage and maintain them. Additionally, GMBRs can help to standardise packaging processes, which can improve compliance and traceability.

Benefits of GMBRs

There are a number of benefits to using GMBRs in packaging, including:

      • Reduced documentation workload: GMBRs can help to reduce the documentation workload associated with packaging. This is because they allow companies to reuse common procedures and documentation across multiple product versions.

      • Improved efficiency: GMBRs can help to improve efficiency in packaging by streamlining processes and reducing the number of steps required. This can lead to faster production cycles and lower costs.

      • Better resource utilisation: GMBRs can help to improve resource utilisation in packaging by making it easier to assign personnel and equipment to specific tasks. This can help to ensure that resources are used in the most efficient way possible.

      • Enhanced compliance: GMBRs can help to enhance compliance in packaging by ensuring that processes are standardised and documented. This can help to reduce the risk of errors and ensure that products meet all regulatory requirements.

    Designing Effective GMBRs

    To be effective, GMBRs must be designed carefully. The following are some key considerations when designing GMBRs:

        • Identify common workflows: The first step is to identify common workflows in the packaging process. This can be done by analysing existing MBRs and identifying procedures and documentation that are common across multiple product versions.

        • Define parameter variations: Once the common workflows have been identified, the next step is to define the parameter variations that exist for each workflow. This includes identifying the different values that each parameter can take on, as well as the conditions under which each value is used.

        • Standardise processes: The final step is to standardise the packaging processes as much as possible. This includes using consistent terminology, procedures, and documentation across all product versions.

      Regulatory Compliance

      When designing GMBRs, it is important to ensure that they comply with all applicable regulations. This includes ensuring that the processes are standardised, documented, and traceable. Additionally, the GMBRs should be reviewed and approved by a qualified person before they are implemented.

      Challenges in GMBR Implementation

      There are a number of challenges that companies may face when implementing GMBRs, including:

          • Quality control: It is important to ensure that the GMBRs are accurate and complete. This can be done by conducting a thorough review of the processes and documentation before implementation.

          • Validation: The GMBRs must be validated to ensure that they are effective in achieving their intended purpose. This involves testing the processes and documentation to ensure that they are followed correctly and that they produce the desired results.

          • Parameter settings: It is important to ensure that the parameter settings in the GMBRs are accurate and up-to-date. This can be done by regularly reviewing the settings and making changes as needed.

        Case Studies

        There are a number of companies that have successfully implemented GMBRs in their packaging processes. For example, Pfizer used GMBRs to reduce the number of MBRs from 1,200 to 200. This resulted in a significant reduction in documentation workload and improved efficiency in the packaging process.

        Future Trends

        The use of GMBRs is expected to continue to grow in the future. This is due to the increasing complexity of packaging processes and the need for companies to improve efficiency and compliance. Additionally, advances in technology, such as automation and data analytics, are making it easier to implement and manage GMBRs.

        Industry Perspectives

        Industry experts believe that GMBRs are a valuable tool for improving packaging efficiency. They point to the benefits of GMBRs, such as reduced documentation workload, improved efficiency, and enhanced compliance. Additionally, they believe that the use of GMBRs is likely to continue to grow in the future.


        Generic Master Batch Records (GMBRs) have emerged as a vital tool for reducing complexity and enhancing efficiency in packaging processes. By grouping similar workflows, they drive standardisation, ensure compliance, and enable companies to manage a diverse range of product versions effectively. The potential of GMBRs is being realised, signalling a bright future for pharmaceutical packaging processes.

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        Łukasz Iskra

        Industrial Software Expert


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