Implementing Serialisation and Track & Trace, by Central Pharma
Central Pharma, one of the largest and most experienced pharmaceutical packing organisations in the UK, has established itself as a contract service provider for niche pharma and global generics companies. Based in Bedford, located centrally in the UK, the MHRA & FDA-approved site is within 1 hour from London, close to the largest port of Felixstowe, and easily accessible by road to mainland Europe. The site offers CMO, CPO and 3PL support for clients, of which over 60% is shipped to export markets. Virtual companies can take advantage of an experienced quality and technical team for full regulatory support.
Since 2012, Central Pharma has invested ahead in serialisation technology needed by its clients to comply with looming global legislative requirements for pharmaceutical serialisation and Track & Trace. In this time, it has been serialising commercial products for India, South Korea and China, as well as for EU and US markets more recently. This sustained investment in capabilities continues to offer compliant products to all markets.
Serialisation is the assignment and application of a unique verifiable product identifier to an individual saleable unit (pack). Traceability, as GS1 defines, enables us to see the movement of prescription drugs across the supply chain. We can trace backwards to identify the supply chain pedigree, i.e. history of the transfers and locations of a product, from the point of manufacture onwards. And we can track forwards to see the intended route of product towards the point of care.
Counterfeiting has long been a threat to patient safety. Track & Trace technology is an essential element of Central Pharma’s service offering for Marketing Authorisation (MA) Holders to enable their products to meet the EU Falsified Medicines Directive (EU FMD), US Drug Supply Chain Security Act (US DSCSA), and other pharmaceutical security regulations worldwide that are in place to combat fake medicines.
Alwyn Smit, Chairman & Chief Executive Officer at Central Pharma, comments:
“Serialisation and aggregation is not an idea that came out yesterday and became legislation. In various forms, some of the big pharma companies have been at it for a very long time trying to find a standardised solution. We made the decision to invest ahead and become experts early on, to be prepared and serve the needs of our customers.”
Central Pharma has collaborated with Boston, U.S. based Tracelink, the world’s largest Track & Trace network and SaaS platform for the life sciences industry. Use of Central Pharma’s Software Licence provides MA Holders with full data access and security, as well as simplified data exchange between MA Holder and regulatory bodies. The validation of these data managed processes, and invaluable experiences gained over the past six years, has prepared the company to ensure that current and future clients are in safe hands regarding their products’ compliance with forthcoming serialisation requirements.
“Our main mission is to ensure supply chain security for our customers. The positive implication of having a more secure product – and more certainty in the supply chain – far outweighs the incremental cost associated with serialisation and aggregation.”