Sometimes the best way to understand the way a process works is to participate in the process. The idea of learning by doing is far from a new one, but it remains true. The Track & Trace User Academy supports the implementation of serialization and aggregation processes, starting with the gathering of first information up to the realization of the implementation.
Listen – Learn – Go live!
Protection against falsified medicines has become a leading issue for the pharmaceutical industry in recent years. All major markets are already calling for measures to protect against product piracy.
With so many new regulations all mandating the implementation of a serialization process there are numerous manufacturers who need to bring their personnel up to speed on using track and trace equipment and processes. In February 2019 serialization of pharmaceuticals will become mandatory in the European Union.
“Time is getting short to set-up a proper system and the needed site organization for a serialized and aggregated production,” Michael Unbehaun, manager engineering site projects, R-Pharm Germany, said. “If a manufacturer hasn´t started yet with a solid implementation project, it definitely is about time.”
Much more than know-how transfer
With a new initiative, the Track & Trace User Academy, manufacturers and the ones responsible for the project implementation are accompanied throughout the whole life cycle to successfully implement track and trace. This practically- oriented concept focuses completely on individual requirements and, step by step, teaches everything they need. Every step is covered, starting with the regulatory demands and diverse applications of systems up to insights into the onboarding-processes and the implementation into the production operation.
Ready for the world market with two strong partners
The practice oriented User Academy, a collaboration of R-Pharm Germany GmbH and Mettler Toledo PCE, helps to reduce the customers ramp-up phase to a minimum.
Participants can expect a broad combination of market information, practical knowledge and implementation recommendations to sustain the delivery capacity and ensure compliance. They can choose, according to the user level, one of the following programs:
■ Site reference visit: you will see how track and trace, from the serialization up to the
complete aggregation, has been implemented in operation – first questions will be answered
during the tour
■ Expert program: workshops, tailor-made to your needs, including discussion about
requirements and the best course of action
■ System training: even during the implementation period we continuously support and
guide you with our experience – from user to user.
If a customer is not able to establish the necessary equipment and procedures in its own facilities in time, R-Pharm can bridge the gap as a contract manufacturer guaranteeing to meet the deadline. To avoid the investment in the regulatory-compliant serialization and aggregation systems, customers may also decide to outsource the packaging to R-Pharm completely.
The CDMO has many years of experience and is certified in over 150 markets worldwide. Among them are all markets where regulations about serialization of pharmaceutical products are already effective, like Korea, China, the US, EU and Saudi Arabia.
To commission a CDMO with serialization and aggregation is a possible solution, but even then, it is now time to act, as capacities might be short soon.
For more information please visit www.r-pharm.de or register for the academy.