The U.S. Food & Drug Administration (FDA) outlines the drug development process in five steps:
- Discovery and development
- Preclinical research
- Clinical trials
- FDA review
- FDA post-market safety monitoring
I caught up with Emerson’s Zuwei Jin whom you may recall from earlier posts on the role of automation in the drug development process.
Zuwei explained to me how manufacturing execution systems (MES), such as Syncade MES can be used in research environment to gather and organize the information required for tech transfer through the drug development process.
Many pharmaceutical and biopharmaceutical manufacturers have been probing around the possibility of using MES in R&D and believe it can be very effectively applied when moving into the clinical and commercial production steps.
Zuwei has shared ways to use Syncade MES Equipment Management, rather than Recipe Authoring (RA), to be the main tool to organize the R&D workflow, documents, and materials. While the production environment is generally considered to be product centric where repeated runs for the same product are performed, the R&D environment can be equipment centric where different experiments are run on the same equipment. Therefore, a MES solution for R&D will be based on Equipment Management rather than RA which has been a norm for production.
MES expanding into R&D does not necessarily replace the existing electronic lab notebook solutions. It does however add exceptional capabilities in organizing research workflow, research planning, equipment logbooks, experimental results, etc. This approach also brings in the MES concept early in the drug development pipeline and it serves as a bridge for better and smoother tech transfer through the pipeline.
The Syncade MES Equipment Management solution provides users the capability to define any kind of state/event transitions or event interactions. This is a critical tool for documentation of activities on equipment in a regulated environment. It is also applicable for research activities in R&D in pharmaceutical industry. What makes the Equipment Management solution a great choice for R&D workflow management includes:
- The equipment state/event transition or event interactions can easily be implemented as equipment class through a GAMP category 4 configuration interface
- The equipment will always have its current equipment state unequivocally activated and only applicable event/events are allowed to perform from the current equipment state
- Event parameters will allow information such as research plan or task ID to be recorded in the event history of the equipment
- Reference documents such as research plan can be attached with relevant events on the equipment
- Materials involved with using the equipment can be managed through the event material property
- Results/files can be attached to correspondent events with relevant research plan ID, experiment ID, or task ID
- Operators and operations staff actions will all be logged, and electronic signature will be collected for all actions performed
- The search capability in Syncade Equipment Management software would enables cross-referencing different equipment for event activities recorded for the equipment. It provides a powerful way of organizing all research works around a research plan with data integrity and in a 21 CFR Part 11 compliant manner
- Events performed for a particular research plan or task can easily be retrieved and organized across different equipment
- The Equipment Management solution can replace all the equipment logbooks and allow instant search for event history on any equipment
- The same Equipment Management solution can also manage the equipment effective status such as calibration and expiration
Learn more in the Manufacturing Execution Systems section on Emerson.com. You can also connect and interact with other MES and pharmaceutical & biotech industry experts in the MES, SCADA & Other Systems discussion forum and Life Sciences group in the Emerson Exchange 365 community.