Serialization / Track & Trace
Serialization / Track & Trace
Preparing for global regulations now!
Patient safety and product integrity are fundamental values and many countries around the world are implementing regulations to fight medicine falsification and ensure that medicines are safe. A unique identifier on the packaging of medicines (serialization) together with an anti-tampering device such as a sealed label ensures the authenticity and integrity of the medicine.
In the European Union the EU FMD (European Falsified Medicine Directive) will come into effect on February 9th 2019, the US DSCSA has been in place since November 2017 and China made serialization compulsory in 2015, to mention just a few. Manufacturers who don’t comply with these regulations cannot sell their drugs to those markets anymore.
This is a big challenge, especially for those companies which deliver products to various countries or work with CMOs, CPOs and 3PLs, but also for CMOs, CPOs and 3PLs who need to comply with the requirements of various customers using different solutions for managing serialization.
This will confront your supply chain and network IT architecture with challenges and will have effects on the rest of your business.
In pharmaceuticals, serialization means machine-readable codes that ensure a globally unique identification in the form of a serial number combined with anti-tampering technology on each individual pack in order to ensure that no falsified medicines come onto the market and to guarantee consumer protection against counterfeit drugs.
In distribution and logistics, track and trace concerns a process of following the movement of a product, determining its current and past locations.
A packaging and logistics functionality which is used to create parent-child relationships throughout packaging hierarchy levels, and which is a starting point for following each individually identified item through its chain of custody.
In a track & trace context, the usual 4-level hierarchy consists of carton, bundle, case and pallet.
Serialization as a legal requirement together with continuous aggregation as a business requirement ensures transparency of product origin all the way to retail sale and creates trust and security in the market.
The best way to set up a Serialization Project
When it comes to planning for serialization, many companies are inclined to start with their packaging lines, technical devices, and other physical components.
But serialization will touch every part of your IT infrastructure, from packaging through to data exchange with CMOs! It’s therefore crucial to begin preparations from the top down in order to eliminate any risk to business.
The biggest challenges are:
- Vendor selection! You need a good level of trust. On-site or cloud solution?
- Interoperability at every layer with all systems – special focus on interfaces!
- Master data management harmonization with systems and various sites and lines
- Stakeholder communication in global and local organizations with experts and QA
- Technology constraints from cloud, SaaS when collaborating with external commercial partners (CMO, CPO, 3PL)
- Upgrading of existing packaging lines to apply serialization, aggregation and tamper evidence
- Integration of various CMOs, CPOs and 3PLs that are using different solutions to manage serial numbers
- Validation and Data Integrity
What HGP can do for you
We will accompany you through the entire lifecycle from the vendor selection, defining the requirements for your serialization solution, through implementation, right up to the support during operations.
- Driving solution selection – on-site or cloud – using a proven method from our 10+ years experience of managing different serialization projects and programs
- Analysis and modeling of serialization processes from packaging lines to ERP systems and serial number management solutions
- Managing the integration of external partners (CMOs, CPOs and 3PLs) including technical interfaces, artwork changes and validation
- Defining the system architecture
- Mitigating data integrity exposure with our state-of-the-art validation approach (CSV) and information risk management methodology (IRM)
- Supporting your serialization infrastructure operations
Why we are the right partner for you
We have 20+ years experience in Pharma and Manufacturing and a strong collaboration background with actors in the pharmaceutical industry including providers, regulators and experts.
HGP supports projects to implement the anti-counterfeiting regulations of various countries. These projects include the implementation of serialization and track & trace systems as well as retrofitting packaging lines with equipment for serialization and anti-tamper device solutions and managing the integration of CMOs, CPOs, and 3PLs into the serialization solutions of MAHs (Market Authorization Holders). HGP experts have supported multi-national corporations with their global serialization and track & trace programs as well as mid-size companies and CMOs.
Since we are aware of the pain points in serialization infrastructure operations, we can help to make the right decision during implementation and help our clients to define and manage ongoing support for their serialization and track & trace infrastructure, including keeping them up-to-date according to latest regulations.
We are profoundly familiar with the applicable standards and actively support, for example, the development of the OPEN-SCS standards as Operations Director.
Have you serialized your lines yet?
HGP is an active member of the Open SCS OPEN-Serialization Communication Standard (SCS) Working Group, an OPC Foundation Working Group. Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. They are committed to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products