Crest Solutions partners with pharma companies in Ireland, the UK, Benelux and Scandinavia to deliver and support solutions for Serialisation and Aggregation from Antares Vision. One such partnership is with a manufacturing facility in Ireland. There a state of the art manufacturing, filling and packaging operation produces close to 800 million units of product on an annual basis. Their serialisation journey began four years ago with compliance for China and Korea. Most recently, compliance was achieved for the FMD. The Project Manager from this site has shared key takeaways based on his experience:
1. Educate yourself
Since the first regulations emerged four to five years ago, multiple sources of knowledge and expertise have emerged. Audit these carefully and leverage what the market has learned to date to inform yourself of exactly what is required for your site and the best way to achieve it.
2. Vendor selection
There are a number of key players in this space. Evaluate them carefully. Consider aspects such as: experience; expertise; support – focus here on the location, remote support is often not enough.
3. Model
From your research on market requirements and vendors, build a business case that covers how the regulation affects your site, your product SKUs, your budgets and your people.
4. Stakeholders
Identify, early on, who are the key stakeholders in your project. Engage them early and be ready to educate and explain: what is involved; what is required of them and; the impact you imagine it will have on the business.
5. Planning and people
Following approval, draw up a detailed project plan and ensure all functional groups are included at each stage. People will be key to the success of your project and its delivery on time and within budget. Engage people early, let them know what is needed from them and communicate with them regularly to keep the project on track.
6. Implementation
As each stage of the technology design progresses, stay in close contact with your vendors (software and automation may come from more than one vendor). Bear in mind any learnings from previous projects that you deem to be relevant. Test systems from your vendor as early as possible for potential weaknesses, even if these are demos rigs.
7. Training
Another key element in the success of this project will be in the embedding of the systems in your facility. Operators and technicians must understand why the systems are required and be given sufficient training to run the systems confidently.
8. Get started
The FMD deadline is fast approaching and this project will take longer than you expect. Vendors have limited bandwidth so mitigate any constraints that you can now and make a move on initiating your project.
