Regulatory changes 'defining' serialization processes: key considerations and opportunities

By Melissa Fassbender contact

- Last updated on GMT

Serialization will be required in the US next year and in Europe in 2019. (Image: iStock/Marko Rupena)
Serialization will be required in the US next year and in Europe in 2019. (Image: iStock/Marko Rupena)

Related tags: Regulation

With deadlines around the corner, companies are beginning to plan their serialization initiatives – a process defined by regulatory changes, says Antares Vision.

In order to learn more about the process, the regulatory changes, specific considerations and issues, and how companies can make sure they are compliant, Outsourcing-Pharma.com talked with Adriano Fusco, Antares Vision’s Strategy and Development Director.

Outsourcing-Pharma.com: How are regulatory changes pushing companies to implement certain serialization processes?

Adriano Fusco​: Regulatory changes aren’t just pushing serialization processes, but actually defining them. Complex serialization programs are, by and large, regulation driven, meaning their deployment in each plant and line is planned to maintain a certain margin of error in terms of meeting the ultimate track and trace deadline.

There’s a “semi-just-in-time” aspect to this, though, because being too far ahead of the deadline can run countercurrent to productivity. A wait-and-see mindset also arises from the tendency for regulations to be significantly delayed or altered in terms of enactment.

Outsourcing-Pharma.com: What are some important issues to take into consideration as companies begin to plan their serialization initiatives?

Fusco:​ The first need any companies must address is effective manpower. To implement a successful, comprehensive serialization program, a company must assemble a competent, experienced team that draws upon cross-sector talents and, ideally, touches nearly all points of the overall business model.

The reason for this multidisciplinary approach is, of course, that the solution – the incorporation of a viable, workable serialization solution – will itself also touch nearly all facets of a business. Track & trace efforts require far-reaching involvement from a variety of niches, including IT, production, procurement, artwork, engineering, etc.

When leveraging the experience from consultants it is important to really assess their competence and experience, and have the right people in place who are able to dedicate a significant chunk of their time to the serialization push. This is generally easier for larger companies to accomplish than smaller ones, typically for workload reasons.

Outsourcing-Pharma.com: What are the main challenges in validation?

Fusco:​ Actually, allow me to turn this question around. I actually see opportunity in the validation process.

Our largest customers – ones that have serialization programs spanning several sites – tend to adopt a unique approach to leverage validation tests across multiple sites.

These efforts bring a number of benefits, such as optimizing the resources of the validation teams and reducing the efforts of the vendor – both of which ultimately result in reduced costs and deployment time, as well as standardized, cross-site compliance protocols for regulations and inspections.

Outsourcing-Pharma.com: How can companies make sure they are compliant?

Fusco:​ First and foremost start as early as possible. The US deadline is around the corner and the EU’s is not far off.

A second piece of advice is to refer to companies with a worldwide footprint and large customers in their portfolio. Such companies are required to provide compliance with all the outstanding regulations and to develop solutions for any new requirements will arise in the future.

With deadline looming, it’s best to go with proven solutions providers. Finally, choose a platform that is modular, so that new mandates can be easily added without the need to reconfigure all systems line-by-line and revalidate the full solution each time.

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