A simple and effective guide to help you implement pharma serialization and traceability projects based on our experience, without drowning or getting lost in the attempt…
We provide traceability services since 2007. Verifarma started in Argentina, where drug traceability regulation came into force in 2011, and that gave us many strengths, knowledge and expertise on the subject.
Once you have defined the roadmap of your project (see Part I: A quick guide to start), you have to plan the project deployment and its continuity over time.
First of all, be careful selecting a serialization software provider, that should be capable to develop standardized configurations and architectures that can be used across multiple facilities and packaging lines. Once you have chosen your serialization partners, you then need to deploy the solution across your manufacturing sites.
Having a cost-effective solution and being able to standardize on your deployment approach to gain efficiencies are extremely important.
As a project rolls out, efficiencies can be gained in the design, build and deployment phases of a project as part of the ongoing analysis and standardization that takes place.
What are the phases of a serialization and traceability project?
There are two main phases to consider: Deployment and Long-term maintenance.
It is common to focus only on the first one, but the second one is as much as important, since long-term compliance will depend on it rather than in the deployment phase.
- DEPLOYMENT – one time activity:
– Project Manager Designation: it is essential for the project success, to designate a Project Manager responsible for the Serialization and Traceability Program.
– Requirements: process analysis, integration (integrate serialization into your existing systems) and interfaces with CMO’s and MAH’s. Regulation compliance impact and validation plan definition.
– Build and Design (development): customization of software solution, interface development and integration with production lines (own and CMO’s) and with MAH’s T&T solution.
– Implementation: Application configuration following design. Integration test in Pilot environment. Users training. Integration with authority’s repository.
– Validation: Software solution validation and equipment qualification in QA instance, according to the validation plan.
– GO LIVE: Production launch. Vendor assistance in the early production stage.
Estimated time for this phase: between 18 and 20 weeks.
- LONG-TERM MAINTENANCE – on going process:
It is very important to ensure the ongoing maintenance of your systems:
– Updates, adaptations and modifications: for new workflows, new partners, technologies updates, new markets.
– Regulations changes: in your local country or new regulations in countries you produce for, and its impact on your current compliance.
– Monitoring: to ensure Compliance with regulatory reporting to the authority, in order to avoid defaults, returns, inspections and sanctions.
– Assistance service for incidents resolution in real time.
Be sure that the chosen serialization vendor provides technical and training support services to manage the transition period during and after the go-live date, and if they have on-line support to find fast resolutions to problems and avoid unexpected line downtime.
Serialization and traceability should be seen as an opportunity to introduce standardized and modernized approaches, as well as achieving serialization compliance. A serialization and traceability project can deliver return on investment through greater visibility of your supply chain, reduction of grey market losses, fewer recalls and improved product quality.
Be sure to make the most of your serialization project to deliver long-term benefits to your organization.
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