It is difficult to underestimate the size of the challenge that serialisation poses to pharmaceutical companies: Large companies and small ones, Contract Manufactures, Parallel Traders, producers of generic products and of branded medicines, all are now tasked to rise to this challenge and expend significant efforts to achieve compliance.
Some – many, hopefully – will be successful, but many – most? – will struggle. And for some serialisation will be a killer.
With the best of intentions – patient safety, the security of the pharmaceutical supply chain and the fight against fraud in all its forms – regulators and legislators have thrown down a challenge that many in the industry are only now beginning to face, when time to implement serialisation is getting seriously short.
We, at 3C Integrity, do not believe this is the case: We work with pharma clients that represent a rich cross-section of the industry and even though their situation, their set-up, their capabilities and requirements vary greatly (and also what will be the best solution for them!), the challenges they face overlap greatly:
And this against the background of existing and emerging requirements, vendors that are rapidly filling up their order books and – at present, at least – persisting areas of uncertainty and change.
We at 3C Integrity share the concerns that have been expressed by other expert observers of this field and have, over the last few months, been giving our opinions in a range of different pharma publications to help build up awareness and understanding of these issues.
The first step to ensuring you’re ready to meet the serialisation challenge is to understand the problems. We hope that the articles above provide a starting point for you to examine your challenges and those of the wider industry. Our pharma serialisation training will guide you through your personal solution to implementing the serialisation requirements of your company.