We are delighted to share with you that Medis has been named as a finalist at the CPhI 2019 Awards, for “Excellence in Pharma: Regulatory Procedures and Compliance”, in relation to our exemplary work around Serialization.
Dedication to quality and compliance
Our dedication to quality and compliance in everything we do is uncompromising. It covers every stage of the development and production of our medicines: from the supply of materials through manufacturing and approval by the strictest authorities in the world. In preparing for the EU Falsified Medicines Directive regulation, Medis introduced a new service to support its customers meet the directives’ goals regarding serialization in optimal, cost-efficient ways. The safety features, stipulated in the EU Falsified Medicines Directive, guarantee medicine authenticity for the benefit of patients, and strengthen the security of the medicine supply chain, from manufacturers to distributors, pharmacies and hospitals.
Through a specialized, dedicated Serialization team, Medis successfully on-boarded a variety of partners which presented different scopes and readiness levels. We achieved this by means of standardization and integrated processes, which resulted in efficient cooperation and communication.
Solving for complexity
When the Directive came into force, the initial scope for Medis meant there were around 350 marketing authorization holders with approximately 4,000 SKUs, supplied by 20 internal Teva manufacturing sites and 15 external contract manufacturers, involving 150+ packaging lines and 20 different IT platforms. Consequently, by standardization of services, we accommodate the scope of the massive EU Falsified Medicines Directive project and make sure our customers are also ready and compliant from day one.
Site readiness is a fundamental piece of the project to understand packaging line status. This is important when it comes to carefully plan serialized orders. IT readiness is complex, as different platforms normally do not offer standardized solutions. To proceed with on-boarding and getting our customers ready, Medis created customized solutions. The key to solving the biggest problems was to manage exceptions and to identify the rationale for prioritization.
Medis offers a standardized serialization portal for its customers, with enhanced data visualization, including real-time graphs enabling the track and trace of project status regarding product, packaging line and IT connectivity readiness, and FAQs providing content to guide customers with a straightforward gated approach. This enables Medis to ensure readiness and competitiveness towards handling worldwide serialization regulation, and in the fight against falsified medicines.
Our employees are truly passionate in their drive for excellence and they inspire us to continually improve our practices so that processes and procedures are continuously updated, to benefit our customers, various stakeholders and, in the end, millions of patients and their caregivers who use our medicines all over the world.
About the Awards
The 16th CPhI Pharma Awards recognize the innovation and dedication of companies and individuals who are driving the pharmaceutical industry forward. Taking place 5 November, the CPhI Pharma Awards celebrate the thinkers and creators driving the industry forward through their innovations, technologies and strategies. Informa Markets, owner and organizer of the CPhI and the CPhI Awards, produces more than 550 international B2B events and brands each year.
Come meet the Medis team at the CPhI Worldwide 2019 in Frankfurt, Germany. November 5-7, on stand 90C10.