Serialisation: the outlook for late adopters
November 4, 2015
Merry Christmas from 3C Integrity
December 18, 2015

Nine top tips to serialisation readiness

3C Integrity have been busy recently speaking at various events and conferences include The TrackTS and FlyPharma conferences. Ian spoke and attended both of these events. During his time at both events he delivered expert serialisation advice and uncovered the current state of serialisation readiness in the pharma sector. We’ve put together a short series of blog posts on our experience at the events.

A few weeks ago Ian had the opportunity to present at the FlyPharma conference in London. Although the presentation was designed to give the conference participants an overview of serialisation, what it is and why it is a challenge and so on, he couldn’t avoid giving some spur of the moment advice to the delegates along the following lines…

  • 1. If you are a pharma delegate and you are not sure what is happening in your company regarding serialisation (and more generally securing the supply chain) – go and find out. Look for the serialisation programme, look for the stakeholder support and look for the budget. Check out whether they have the scope properly defined and understood.
  • 2. If they don’t know or tell you it is easy or that they have plenty of time – be afraid, be very afraid!
  • 3. If you are not a pharma delegate but participate in the pharma supply chain, talk to your customers and find out about their state of readiness – and as a result of this find out whether they will be your customers in the future. Find out what role if any they expect you as a supply chain partner to play in their programme.
  • 4. Ask your clients about the impact on the supply chain of the emerging serialisation requirements – they may require temporary or even permanent supply chain reconfiguration or constraints – how will this affect you? Have a look at any planned supply chain reconfiguration projects that are in the works – make sure that the impact of serialisation has been considered.
  • 5. Multi market packs are a particular concern and losing these may lead to a degree of pack proliferation and complexity as market specific packs are brought onto the range – look out for any in-market pack modifications that may no longer be possible with the advent of tamper evidence.
  • 6. The manufacturers should be on top of this stuff but many are not – those that are, are being encouraged to evaluate their supply chain partners and categorise them as low or high risk – mitigation for the high risk players may well involve exiting. Find out what category you are in.
  • 7. There are almost certainly opportunities here which you could take advantage of – many late adopting companies will be looking for tactical serialisation solutions – can you help them with this – can you do it for them?
  • 8. An earlier presentation reported that the biggest customer concern is visibility – where is my product? Can you leverage serialisation to alleviate this concern?
  • 9. Finally, given that the fundamental objective here is to protect patients by securing the supply chain – what assurance can you give your clients about the security of the product when it is in your hands – you probably have a QMS, do you have an SMS (security management system)?

For more expert advice, get in touch with 3C Integrity

At 3C Integrity we regularly run innovative, vendor-independent training events that offer a unique and invaluable chance to ensure your programme is on the right course. Our next one-day serialisation training event is taking place on the 12th November in Milan, we also provide in-house training events and consultancy for clients across the world contact for more information.

Download this short series of blog posts as a free white paper resource from our website. We have a wide range of additional pharma serialisation advice to download from serial number management to 10 things pharma manufacturers need to consider to be ready for the EU-FMD.

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