Alyn McNaughton, technical director for Lonza Edinburgh, Lonza Pharma & Biotech discusses the requirements and regulations surrounding serialisation legislation.
Regulations
Whilst there has been general agreement amongst countries around the world regarding the need to guard against drug counterfeiting and ensure drug security, consensus is not yet formed on how best to address the issue. It is broadly accepted that serialisation plays a vital role, but how best to generate, manage and record data across the supply chain remains a hot topic of debate. The one thing I can say with absolute certainty about serialisation is that by the time this article is published it will already be out of date.