Overcoming the EBR challenge for smaller pharma manufacturing sites
How can smaller pharma sites get world class EBR?
Here’s a common situation:
Smaller pharma manufacturing sites and Tier 2 and 3 sites in large pharma enterprises often fail to get the manufacturing technology they need.
The problem is that,
Large pharma enterprises frequently select technology solutions at a corporate or global level, they want to buy fewer systems from a small number of vendors which can deliver a large range of capabilities. The large IT vendors have positioned themselves and their products to serve this market and so produce full function MES solutions which have a high cost of implementation in both financial and human resource terms. Tier 2 and 3 sites of enterprise pharma companies cannot implement these systems due to cost and solution fit issues. Smaller manufacturing companies equally find that the costs are prohibitive, and they can't support the complex implementation projects with their more limited resources.
Why does this happen?
Large pharma company’s IT departments want to create and maintain a simple IT landscape with fewer, scalable solutions offering all the process capabilities that their customers (i.e. other internal departments) might need or want. The big production sites want a solution that can manage batch records, equipment calibrations, inventory management, weigh and dispense etc with 2-way integrations to their ERP, LIMS and data historian. These solutions offer the full service MES for the top tier pharma manufacturers in an integrated package. The consequence of this is a large Business and IT programme which requires highly skilled consultants, systems integrators, business analysts, validation experts and business process SME's to deliver it over a period of months. These are significant investments which need big benefits to justify the return on investment and will typically payback over a number of years. (Factorytalks CEO David Margetts writes more about Learning From The Past To Improve EBR here on our sister companies website)
Smaller Pharma companies and the smaller sites in large companies such as market entry sites, early stage development and clinical manufacturing sites, do not fit into the model described above. They neither need nor want such a significant investment and the impact of implementing such a system could be crippling. The capital costs have to be paid for in depreciation over many years even if the global organisation pays for the initial investment and the license fees will consume a significant part of their ongoing expenses budget which will limit their ability to spend on smaller, new technology projects or experiment with new equipment which might give a larger return for their style of manufacturing.
In addition to these problems, the enterprise MES solutions are not always agile enough to fit in with their production characteristics. In a contract manufacturing organisation for example, they may have short notice demand for a small batch of a new product and often they require a change at the last minute. This is also true of early stage manufacturing. In these cases, an MES which requires a consultant to configure the EBR prior to it being available for manufacturing just can’t respond to the timescales and cost structure that these companies work at.
So, what can be done about this?
The solution to these problems is not to try to force-fit an enterprise MES into a small site's IT architecture. Simply installing it in the cloud or reducing some of the modules available doesn’t work as the basic design and structure of the MES isn’t built for fast response, low cost and small, changing production demands. The answer is a new design of solution designed especially for these types of manufacturing scenarios.
One solution that fits these needs is the BatchLine EBR System. BatchLine provides one element of an MES and delivers it in a way that suits the smaller manufacturing site. By focussing on just what is needed to create a fully compliant batch manufacturing record, the costs are kept low and the speed to value high. Deployments on a multi or private tenant cloud or on-premise allows the company to implement based on their particular risk/cost profile and this can easily be changed at a later date if that profile alters. Training takes a few hours and by using a commonly available tool to author the batch instructions, anyone who knows their manufacturing process can build the batch record template. Full GXP controls such as error proofing data entry, e-signatures and auditable traceability provide the compliance requirements and the capability to simply review the batch record by exception massively reduces the time to perform batch review and release for sale. This can even be done concurrently with manufacture.
A call to action,
In conclusion, pharmaceutical manufacturers who operate smaller production facilities, pilot plants and contract manufacturing sites should take a look at the solutions for EBR from smaller companies who are bringing new technology and fresh design thinking to solve problems which differentiate this style of manufacturing from the large enterprise thinking. Heads of quality, production and IT should take a look at these solutions and find out how they can deliver rapid benefits, cost effectively and fully compliantly.