qhv...the company in question had surveyed their cmos and categorised them red, amber, or green...

Ian Haynes

3C Integrity | WWW.3CINTEGRITY.COM 1

About 3C Integrity ............................................................. 2

Sharing best practice ........................................................ 2

FlyPharma ........................................................................ 2

Trackts! 2015 ................................................................... 2

Serialisation and the wider system landscape ..................... 4

The wider system landscape ............................................... 4

Get ready for serialisation to stay in the supply chain ........ 5

Serialisation: the outlook for late adopters ...................... 6

Stakeholder Engagement ................................................... 6

Strategies for Late Adopters ............................................. 7

Nine top tips to serialisation readiness ...................................................... 8


3C Integrity are widely recognised as leading experts on pharma serialisation, offering over a

dozen years of experience ranging from setting the high-level product security strategy to the

details of implementing coding and serialisation solutions in the pharmaceutical industry.

Our core capability is strategic consulting on product security, serialisation/traceability and coding

which we deliver in close collaboration on customer implementation projects or through our unique

Pharma Serialisation Training.

As experienced practitioners we have a deep understanding of the elements and endeavours that

drive external traceability requirements and maintain a close engagement with projects that are

shaping the future context in this field such as the EFPIA-led ESM response to the EU-FMD and

SecurPharm in Germany.

We place great importance on our solution- and vendor independence because we recognise that

different customers may have very different needs. A solution that is perfect for one case may be

the wrong approach for a company that has different requirements and faces different constraints.

Our aim is instead to help customers identify and select the approach, solution and the right

partners and to work with them to make their implementation a success.

As part of our continuing work to aid the implementation of serialisation across Europe and the rest

of the World we share our best practice at conferences and events including our own vendor-

independent training events.

In September 2015, Ian Haynes, attended and spoke at two conferences:

Taking place at London Heathrow this two-day conference assembled a range of industry experts

to focus on relevant topics to pharma supply chains. The conference focused on candid,

contentious and challenging content that would leave delegates inspired and informed. Ian

presented a 'Security Alert‟ session focusing on serialisation and the pharma supply chain.

http://www.flypharmaconference.com

This two-day conference was organised by we.conect and brought together global players and

hidden champions of the pharmaceutical industry. Aiming to benchmark the latest developments

http://www.flypharmaconference.com/


as well as providing an overview of how to solve the challenges of serialisation, the conference

focused on presentations and round table discussions. As part of this conference Ian led a World

Café session focusing on Late Adopters.

http://serialization-conference.com

As a result of Ian‟s experience at these events he has put together a short series of blog posts

available on our website and also here in one complete resource.

http://serialization-conference.com/


The TRACKTs! 2015 conference covered familiar ground to a great extent with presenters

delivering case studies from both big and small pharma, solution providers describing the virtues of

their particular approaches and others describing the twists and turns of the regulatory landscape,

however I did also feel that there were some new themes beginning to emerge.

The first of these was the recognition that – as we have termed it – “the wider system

landscape” is critical. A pharma company‟s ability to meet the current and emerging regulations

is critically dependent upon the capabilities in the wider supply chain. This includes any CMOs in

play, and any supply and distribution partners handling the product on behalf of the MAH prior to

the point of change in title. Implementations to date have focussed to a great extent on the in-

house manufacturing capability and only now are companies beginning to turn their attention to

their supply chain partners.

A case in point was the excellent presentation by a tier one pharma. The presenter reported that:

27 internal manufacturing lines had been made ready for serialisation

40 further internal manufacturing lines were still to be made ready (a challenge in itself)

No CMOs in the supply chain had been connected

1 „serialisation savvy‟ CMO is on a pilot project but 10 months in they are still not

connected.

Based on these figures the presenter went on to say that:

15 organisations need to be connected per year to be ready for the EU-FMD requirements

10 CMOs per year is the limit to the integration process, they found it unscalable beyond

that

500 internal man days are being devoted to the project

The company in question had surveyed their CMOs and categorised them red, amber, or green

according to the likelihood that they will be ready and integrated on time:

30% of their current CMOs are in the red category

16% in amber


almost 50% of their CMOs are considered to be at real risk of not being ready on time,

putting the effected products at risk.

Strategies being considered to mitigate this risk were to abandon the products in question –

perhaps low margin/low volume products that could not justify the investment of the alternative

strategies of bringing the manufacture back in house, or tech transferring to safer pairs of hands.

The message arising from this for manufacturers if clear – look to your wider system landscape

sooner rather than later, assess the risk and be ready to take some tough decisions in order to

secure your supply.

The message for CMOs is also clear – in order to stay in the game you must achieve a state of

readiness for serialisation and simplify your connection to your clients serialisation systems or you

risk being cut out of the supply chain all together.

The second theme was that people are beginning to discuss the outlook for the later adopters –

these are companies who for whatever reason choose to ignore the evidence presented in the

many case studies about the scale and complexity of serialisation implementation, and are still “on-

hold” waiting to start their own programmes. Whilst many may be banking on the requirements

being postponed in the face of a poor state of readiness in the industry, commentators close to the

EU seem adamant that this will not be the case.

Whilst a lot of the discussion was around finding ways of engaging the senior stakeholders in order

to simply get the programmes underway, it is clear that the programmes of the late adopters will

have to find ways to accelerate their progress, perhaps as Thomas Brückner (Vice Chairman and

member of the Executive Board- securPharm e.V. and Head of Pharmaceutical Affairs, GMN,

Medical Devices – German Pharmaceutical Industry Association (BPI) e.V.) suggested they will

have to do “strange and new things – and break some rules” in order to be ready on time.


At the recent TrackTS conference Ian ran a “world café” discussing the outlook for late adopters.

The conference delegates organised into 4 smaller groups joined Ian at a white board and flip chart

(his favourite place!) to progress a rolling discussion on the outlook for late adopters.

It was notable that there was much less “denial” amongst the delegates than has previously

been the case in similar discussions. Although there were comments suggesting that the

continuing lack of clarity about the regulatory requirements was creating a barrier in some

organisations, the majority view was clearly that there was – and has been for some considerable

time – adequate definition to allow projects to proceed confidently. The likelihood of the national

systems being ready in time was questioned, but the majority of delegates were keen to explore

the remaining barriers to starting projects, and then the strategies that might be employed

allowing late adopters to execute quickly.

As we have said many times before, the single biggest challenge in any serialisation programme is

stakeholder engagement. The delegates identified the need for a “killer presentation” that could be

given to senior stakeholders combined with the creation of the right external environment to break

the deadlock.

The presentation would need to wave the right flag for the stakeholders in question – almost

certainly this is going to be the regulatory compliance/license-to-operate flag, something that all

stakeholders will recognise. At the same time it is vital that the presentation gives a realistic picture

of the scale, scope and complexity of the work ahead and thus highlights the necessity to start as

early as possible. Describing benefits beyond compliance was also felt to be a major part of the

story – business value through improved supply chain visibility might be attractive as might be the

possibility to achieve greater levels of patient engagement.

In terms of the external environment delegates felt that the national associates may not be fully on

board and could play a greater role in terms of encouraging pharmas to engage. At the same time

it was felt that creating some consumer pull for serialisation would be very beneficial. At this stage

this pull could be generated by describing the possible benefits consumers could experience in a

serialised world of medicine – far better this than wait for a counterfeit event that results in

significant patient harm to create a pull from consumers. In this latter scenario the apparent


reluctance of the pharma manufacturers to comply with the planned legislation would be difficult for

consumers to understand.

Whilst the bulk of comment was around barriers to engagement, there were some ideas that could

lead to more rapid execution of serialisation programmes. Bandwidth in the supply base was a key

concern with many of the experienced vendors being badly stretched already. Key ideas in this

area were to make sure you were an easy customer to work with and the following list gives some

insights into what this might mean:

Be an educated customer – take steps to build your knowledge early

Get experienced help particularly when it comes to building your URS – build on the work of

others

Act like a single customer and not many customers – employ standardisation and look for

scalable templated solutions that can be deployed around your network

You will need to build a consortium of vendors – treat them as partners and consider pre-

configured alliances between adjacent solution providers where they exist

Revisit your vendor selection processes – what can you afford to do – what have you got

time to do? Good enough may well be good enough!

More general advice suggested the following;

Be realistic about what you can achieve in terms of L4 system integration

Get your requirements radar and impact assessment process in place early – identify your

sources of intelligence

Consider re-investment and re-training of staff as early as possible before the arrival of the

new serialisation systems

Identify early the need for tactical solutions where it is clear your programme will not meet

the requirements on time and put these in place

Be ready to do strange things and to break some rules.


Ian had the opportunity to present at the FlyPharma conference in London. Although his

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…

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.

If they don’t know or tell you it is easy or that they have plenty of time – be afraid, be

very afraid!

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.

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.

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.

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.

http://www.flypharmaconference.com/


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?

An earlier presentation reported that the biggest customer concern is visibility –

where is my product? Can you leverage serialisation to alleviate this concern?

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)?

Specialist Pharma Consultants providing expertise in product security, coding and serialisation for manufacturers and solution providers.

www.3CIntegrity.com

qhv...the company in question had surveyed their cmos and categorised them red, amber, or green...

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