IBSA and the digitisation challenge: Electronic Batch Record30 September 2021
On Thursday, September 23rd, at the IBSA Group's production plant in Lamone (CH), a new management system to automate electronic batch records (EBRs) of the progesterone batch packaging, a hormone used in Medically Assisted Procreation (PMA) techniques, was released.
This system, which was authorised by Swissmedic a year ago, is fully digitalised and represents a further important step in the digital transformation process undertaken by IBSA. Specifically, this is the first important milestone in the digitisation of the Master Batch Record - the official instructions that guarantee that each stage of processing is correctly carried out and documented - in both the Swiss and Italian sites. Indeed, this is a very complex process, not only because the pharmaceutical sector is highly regulated, but also because this innovation applies to a system that impacts the entire production chain.
IBSA'S SUSTAINABLE PATH CONTINUES
This system, which enables a more accurate, efficient and safer process of production and approval of the finished product, also fits fits perfectly into IBSA's sustainability path.
Not only does this result in a drastic reduction in paper consumption, but also in the simplification and optimisation of the workflow and batch release process, which have to follow very strict procedures.
With the implementation of this new system, which is fully compliant with current cGMP (current Good Manufacturing Practices) regulations, IBSA renews its promise of innovation as an intrinsic value of its modus operandi, both in terms of products and production processes, confirming its commitment to raising its quality standards.
THE IMPORTANCE OF COLLABORATION
This remarkable achievement resulted from the synergy between three different departments. A cohesive and motivated multi-departmental team was essential to the success of this project. Quality Assurance, Production and Information Technology, strengthened by a common vision, have successfully implemented what can be considered a real revolution in operations related to production processes.