Serialisation Killers?

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.

Scary Stuff – Scaremongering?

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:

• Understanding what the requirements are that drive their response;
• Determining the right approach and direction for their readiness programme;
• Getting their senior stakeholder buy-in;
• Identifying the relevant use-cases;
• Defining a high-quality User Requirements Specification;
• Selecting the right vendor for the job;
• Co-ordinating the implementation programme across the many parts of the company that are affected;
• Seeing through a complex, multi-layered implementation programme, from start to finish.

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.

Check out recent articles and comment pieces such as:

• Pf (Pharma Field) magazine which you can subscribe and download for free from www.pharmafield.co.uk and then read a full double page spread where Christoph Krahenbuhl analyses European medicine compliance while scrutinising the challenges that UK pharma faces.
• PackagingNews where we look at explore the topic ‘Has UK Pharma lost its Euro-Vision?’
• Securing Industry (our media partner for our training event) saw Christoph speak about the surprises within the EU ‘Safety Features’ Delegated Act.
• PharmaTech Talk where Ian Haynes examines ‘CMOs and the Track-and-Trace Race:Are you engaged yet?’ and the first practical step that contract manufacturing organisations need to take ahead of implementing a compliance strategy.

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.

A helping hand

Find out more about our pharma serialisation workshop which takes place on the 23-24 September or contact Christoph or Ian at events@3cIntegrity.com for more information.