Do you comply with the regulations affecting serialization?
The regulatory landscape for pharmaceutical packaging has changed dramatically over the last decade. In order to protect and empower the consumer, great deal of regulations addressing supply chain and serialization were introduced.
In short, pharmaceutical serialization is the process of tracking and tracing the route of prescription drugs through the supply chain from manufacturing to dispensing. The most common “track and trace” technologies for serialization include:
- Inkjet systems
- Laser marking
- Thermal transfer/direct thermal
Serialization is a complex process that involves more and more regulations making it harder for global and multinational pharmaceutical companies to comply with them. Specifically within US, serialization laws are defined by Drug Supply Chain Security Act (DSCSA).
According to DSCSA, pharmaceutical manufacturers, re-packagers, wholesalers, and third party logistics providers must implement “track and trace” serialization technologies and determine the validity of the product by 2023. However, you would need to comply with additional/modified serialization requirements depending on country/region.
It is not easy to comply with all requirements and regulations with regards to serialization. The 10th annual Pharma Packaging & Labeling East Coast conference is designed to help you to understand where your company stands with regards to serialization and compliance. High calibre speakers will be strategically guiding you towards the successful and compliant serialization.
Matt Sample – Sr. Director, Secure Supply Chain at BluePoint Laboratories – will be bringing a wonderful session “Finalizing the serialization process; uncovering the final components needed to ensure compliance”. His presentation will cover:
- FDA’s push back for serialization guidelines and its implication on your implementation timeline
- Enhancing serialization knowledge to ensure you are fully compliant with regulatory requirements
- Reviewing serialization implemented around the world to minimize errors
Bob Celeste – Founder of the Center for Supply Chain Studies – will be exploiting blockchain technology to ensure compliance with the Drug Supply Chain Security Act (DSCSA). He will also outline best serialization practices to enable small and mid-size pharma to ensure compliance.
Stay ahead of competition by making sure that your company complies with serialization regulations. Join the most anticipated pharma packaging event to learn more – don’t look at serialization as a challenge, take it as the opportunity.
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