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Agnes Shanley is senior editor of Pharmaceutical Technology.
The contract development and manufacturing organization (CDMO) Aesica Pharmaceuticals has had a serialization program in place for the past five years, and recently installed capabilities for serialization at all its packaging facilities.
The contract development and manufacturing organization (CDMO) Aesica Pharmaceuticals has had a serialization program in place for the past five years, and recently installed capabilities for serialization at all its packaging facilities. As operations director Catherine Kay notes, customer readiness varies widely, and working with smaller virtual pharma and small-to-mid-sized pharma companies can be challenging, especially since some have not yet formulated strategies or implementation plans. The company recently designated a new staff position at its UK facility, expressly to help improve communications with customers and knowledge transfer.
The company has also been installing aggregation capability at its facilities. Ms. Kay recently brought Pharmaceutical Technology up to date.
PharmTech: What do you think of the FDA’s recent postponement of the Drug Supply Chain Safety Act’s (DSCSA) serialization enforcement?
Kay: In some ways, the news came as a bit of a surprise. Serialization efforts have been going on for quite a few years, and, at many industry events, the message was repeated that the date had been set. But I guess that regulators realized that many smaller and virtual companies aren’t ready yet.
PharmTech: As a CDMO, what have you seen as the greatest challenges in setting up a serialization program for clients that is flexible enough to handle diverse client needs, yet rigorous and deep enough to work for different national requirements?
Kay: Our large pharma clients have been very organized in specifying the scope of their serialization projects, defining what they want, and how they want to provide numbers and receive data, as well as what the trigger points should be for receiving data. When we began our serialization journey five years ago, we found that this group of customers was ahead of the regulations.
It has been challenging, however, to gain engagement from some of our smaller to medium, and virtual pharma clients, for products that we already package for them for the EU market, and to understand the scope of their requirements. Some clients have not fully mapped out their processes and requirements, for example, the optimal format for transmitting and receiving data. To push those thought processes, we have developed standard templates and share with them what we can provide so that we can then work with them to arrive at that detailed scope of supply.
The other challenge is determining the trigger points for when the data need to be transmitted. Some smaller clients want to receive serial numbers at the point of shipping and others at the point of QC and product release. It’s the marketing authorization holder’s responsibility to ensure that those numbers are transmitted to the regulatory authority, but we are doing all we can to support them so that they meet these requirements.
PharmTech: Have you launched any new initiatives within the past year?
Kay: We have been working on serialization for a number of years. Most recently, we made a conscious decision to make sure that all of our sites are serialization ready. We felt that we needed to be prepared for where the market is going. Our lines can also aggregate to the shipper and the pallet level. Some of that has been driven by our larger pharma companies, and aggregation is now seen as a key enabler to the future of track and trace.
PharmTech: Do you find yourself educating clients on best practices?
Kay: Experts at the site level are sharing knowledge, especially with smaller pharma clients. At our UK facility in Queensborough, for example, we created a new position: client implementation manager for serialization, to work with clients, aid with engagement, and share information proactively. We see client education as a key part of our role.
PharmTech: Do you offer clients a ‘quick compliance’ option?
Kay: We don’t have an accelerated program but we can offer some quick solutions such as printing cartons and labels off line and verifying them during the packaging process. What we can achieve when we take this approach depends on the scale of customer requirements and whether changes are needed to the artwork, which, depending on the market, could need approval. Timelines can be challenging, but delivering rapid solutions can be achieved by working in true partnership, in which both parties have clarity on requirements and activities.
PharmTech: What will happen to firms that continue to put off serialization?
Kay: I find it difficult to believe that some people still aren’t taking this seriously, certainly within the EU, where regulators have made it quite clear that you won’t be able to sell a product without a product identifier after the 2019 deadline. This requirement has been out there for such a long time that I can’t see the deadline being extended. People have to look at investing, and examining the options available to meet that need. Whether pharmacies will be ready at the point of dispensing remains an open question, but manufacturers will have to do this or they won’t be able to sell products, and CDMOs won’t be able to offer services if they don’t support compliance.
PharmTech: What types of IT solutions are you working with?
Kay: We use different solutions, depending on the site. In the UK, for example, we partner with TraceLink, using its cloud-based solution. In Germany we have a partnership with Avarto, to use a data management system that links into the SAP system and then, through an interface, into our customers’ IT systems, so we have experience with different systems.
Pharmaceutical TechnologySupplement: Outsourcing Resources
When referring to this article, please cite it as A. Shanley, "Serialization at Aesica: An Interview with Catherine Kay, Operations Director," Pharmaceutical Technology Outsourcing Resources Supplement (August 2017).