WE SMOOTH OUT
YOUR ROAD TO DRUG SERIALIZATION COMPLIANCE
Drug serialization is becoming a major challenge for the pharmaceutical industry as regulations are or will soon be in place in more than 40 countries.
The deadlines for compliance with the Drug Supply Chain Security Act (DSCSA) in the United States or the Falsified Medicines Directive 2011/62/EU (EU-FMD) in Europe have marked important steps for the pharma industry.
Whether you are a pharma company, a contract manufacturer (CMO) or contract packager (CPO), you will need to ensure that prescription medicines shipped from the manufacturing sites are serialized.
By the end of the decade, 80% of global drug supply will be serialized. Thousands of sites and packaging lines will be impacted by legal and regulatory requirements. With fast approaching deadlines and to avoid to put your business at risk, you will need a serialization solution that is quickly and easily deployable at your sites and works seamlessly with your existing line equipment and your enterprise information systems.
Legal requirements for the serialization of pharmaceutical products can differ vastly from one country to another in terms of scope, coding format, incident reporting, data storage and exchange etc. they can change without notice. To be compliant with a range of different rules and regulations, you need a solution that is fully configurable, highly flexible and adaptable to the ever-changing legal landscape surrounding drugs and medicines.
Implementing new industrial processes across production plants and lines is always a delicate operation that can make lengthy change control necessary. To minimize downtimes, you need a centralized configuration and process management software at site level that also enables you to keep up-to-date with changing regulations easily and to ensure fast and seamless changeovers for all your packaging lines without compromising Overall Equipment Efficiency (OEE).
Calculating the costs of serialization requires a holistic examination of the multiple elements impacting your implementation strategy. To avoid hidden costs related to software/hardware incompatibilities and change management, you need a standardized and highly scalable software solution deployed by a reliable and qualified system integrator.
A pharmaceutical company usually handles hundreds of thousands of prescription drugs every year. With serialization mandates, it represents millions of serial numbers to generate, plus product master data, events to report and huge amounts of information to be securely stored, indexed and exchanged with authorities and supply chain partners or CMOs. A level 4 serialization traceability solution can address the challenge of serialization data management. But a future proof solution should provide a trusted cloud native architecture with the highest standard of security plus exceptional connectivity with third parties, and the flexibility to ensure permanent compliance.
How can I create value for my business out of the massive amount of serialization data?
Once the compliance objective fulfilled, Pharmaceutical companies and CMOs should be able to benefit from the massive amounts of data generated during the serialization and track & trace process. Future proof serialization and traceability solutions should open new horizons to create value beyond regulatory compliance, in terms of data analysis, machine learning tools, and additional capabilities through existing in-house or third-party solutions.
Adents is the leading provider of end-to-end traceability solutions to secure local and global supply chains.
We help pharmaceutical companies, Contract Manufacturing Organizations (CMOs) and their Supply Chain Partners to adapt to market changes and comply with regulations on drug traceability with the only integrated serialization solution covering all track and Trace needs, seamlessly.
What do you
need to achieve ?
With current laws and scalable for future legislations
big data ready
Securely leverage the business potential of your data with the latest technologies
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If you cater for the American market, you need to start putting together a serialization implementation strategy now if you want to be compliant and operational in time with the DSCSA requirements.
This case study examines implementation of drug serialization and aggregation for a top leading European CMO on 4 sites, 7 lines to address 4 different export markets.