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Supporting machine IT integration in pharma manufacturing

Good Automated Manufacturing Practice (GAMP) Italia has put together a set of requirements for data integration between production systems and higher levels in life science manufacturing. Here, we explain how the User Requirement Specification (URS) aims to improve interoperability and support integrated production lines.


As part of the GAMP communities of practice (CoP) of the International Society for Pharmaceutical Engineering (ISPE), GAMP Italia has taken a significant step toward addressing the challenges of data integration in life science manufacturing. To facilitate improved machine communication and streamline the integration of production systems with higher-level platforms like manufacturing execution systems (MES), GAMP Italia has formed the “Connected Machines” working group.


A collaborative effort by experts

The group comprises a diverse range of participants, including subject matter experts from pharmaceutical industry, machine builders, software technology producers, consultants in computer system validation, regulatory authorities and education professionals. As a leader in automation and digitalization with significant experience in the life sciences sector, COPA-DATA has contributed its expertise in digitalization for pharmaceutical manufacturing to the group. By bringing together various perspectives and competencies, the group aims to define a comprehensive set of requirements for machine data integration in life science manufacturing.

The ultimate goal is to improve the connectivity of machines and systems, develop guidelines for machine integration, and simplify the process for pharmaceutical companies seeking to incorporate machines into their production lines. To achieve this, the group has developed a comprehensive User Requirement Specification (URS) document aimed at providing guidance and establishing minimum requirements for data integration in the industry.

The URS is a 78-page document developed collaboratively by 22 contributors from the Connected Machines working group. It serves as a tutorial for anyone involved in integrating machines into their network infrastructure within the pharmaceutical industry. The document outlines specific requirements reviewed by experts in the life science sector. It is designed to support pharmaceutical companies in effectively communicating their needs to machine suppliers, assisting machine builders in designing machines that connect easily to centralized systems, and aiding consultants in facilitating better-connected solutions.


Streamlining integration and validation

The inspiration behind the URS stems from the challenges faced by pharmaceutical companies when adding new machines and equipment into their existing systems. Typically, experts in pharmaceutical management develop integration specifications with a strong focus on quality, efficiency, and performance. However, their lack of specific experience in digitalization often results in generic specifications. Machine builders then interpret these generic requirements independently, leading to varying approaches. Consequently, when the machines arrive at pharmaceutical companies, connecting them to IT systems becomes complex and costly due to discrepancies between integration concepts and the subsequent validation processes. This challenge motivated the creation of the URS as a template to support this process.

The URS outlines the purpose of the document itself, its benefits, and a comparison of regulatory requirements related to data connectivity. It also covers more general requirements applicable to all machines, such as recipes, alarm management and cybersecurity. These requirements are derived from real-life cases regarding projects that pharmaceutical industries have conducted with the support of machine builders. The URS also provides detailed requirements specific to machines used in pharmaceutical production lines. It uses real-life examples and instructions to guide users in meeting the requirements.

The URS template is valuable to a wide range of professionals. Engineers can use the document to gain insights into machine specifications necessary for delivering an audit trail or designing recipes. Automation and IT professionals can better understand the expectations from machine builders. Quality assurance teams benefit from the document's summary of relevant regulations pertaining to digital integration. The URS acts as a common language, promoting collaboration among different professions. Designed for simplicity and accessibility, it is useful for anyone with a minimum of a basic knowledge of machinery and pharmaceutical production.


What’s coming next?

Following finalization, the URS has been shared with GAMP European Steering Committee and ISPE Pharma 4.0 Plug & Produce working group. As next step, the working group plans to explore the implications of the newly released GAMP 5 second edition guidelines on connected machines and evaluate plug-and-play approaches and real case studies to reduce connection time and cost for existing machines. The working group collaborates with the international ISPE Pharma 4.0 CoP to align their efforts with global standards and best practices.

GAMP Italia's Connected Machines working group has taken a significant stride towards addressing the challenges of data integration in life science manufacturing. The URS document serves as a crucial resource for the industry, providing standardized guidelines for machine integration and promoting interoperability across production systems and higher-level systems. As the working group continues to refine the URS and explore new methodologies, the vision of integrated and connected production lines in life science manufacturing will only become more attainable.


To access the document, contact Giuseppe Menin or Marco Bellentani.

Find out more here.