My April column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ:

Tips for your serialisation Strategy – Tips 1 and 2

To read it, please click here:

We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

Posted in Articles, Serialization | Tagged , | Leave a comment

Proactive Strategies for Track and Trace Deployment – Highlights from the CMO Serialisation Seminar UK

Sheraton Skyline hotel – 30 March 2016, London

Yesterday I had the opportunity to attend a one-day Serialisation conference – CMO Seminar UK – Proactive Strategies for Track and Trace Deployment.  Organised by Optel Vision, TraceLink and Be4ward, the objective of the conference was to help explain the requirements of Serialisation to CMO organisations and provide guidance on how to approach their Serialisation implementations. Speakers presented on a range of topics, including:

Serialisation implementation from a CMO perspective
Dave Hodgson, Technical Director, Central Pharma Ltd
Dave presented on the learnings Central Pharma have gained through their serialisation deployment activities.  Supplying over 60 markets worldwide with Pharmaceuticals and Nutraceuticals, Central Pharma are proving serialised products to China and India.

A key learning was understanding that some of the service providers were learning about the technologies and the market place, so early projects were as much a learning experience for the service providers as Central Pharma.  This impacted both timelines and the quality of advice from the provider.  Some of the technical solutions that were planned proved infeasible, for example it was planned to use much of the existing line printing equipment, but new equipment was actually required.  Selection of scanning equipment also proved challenging due to the range of solutions with widely varying technical capabilities available.

Dave emphasised that having a clear IT strategy is important to ensure that data flows, data handling, response times, and file formats are all adequately considered.  Requirements to link with other sites and customers also need to be defined and agreed.  User Requirement Specifications need to ensure that all requirements have been accurately captured, e.g. serialisation number formats and character lengths.  If not, there is a risk that chosen equipment and systems will not meet the detail of your requirements and result in costly and time-consuming rework.

Implementing Serialisation Pilot Project
Aladin Alkhawam, Director, Packaging, Par Pharmaceutical
Aladin presented on Par’s experience with their Serialisation implementation to meet the US Track and Trace requirements.  This legislation is some of the most stringent serialisation legislation in the world.

Par established their programme in mid-2014.  They were particularly concerned about the availability of skilled resource.  They also only wanted to impact lines only once, so needed to implement serialisation and aggregation in one go.

They realised that Serialisation impacts every part of the company, so established cross-functional governance and a cross-functional programme team to help develop their strategy and funding approach.  Solutions are expensive with little return on investment, but you have to comply to continue to supply impacted markets.

They undertook a pilot on a single packing line to learn about what they needed to do and what issues would have to be addressed to support a global roll-out.  From April this year, Par will have a packing line go live every month for 18 months.  This takes resource and also careful planning to minimise downtime.  Selection of experienced appropriate partners is also seen as essential to support this programme.

They have also planned the cutover of SKUs to meet the plan as artwork will have to be updated and new components provided.  The recent Endo acquisition for Par requires all artwork to be changed, so this has allowed them to consolidate changes.  They also have to update their batch records to account for serialised product.

They have introduced measuring OEE to understand the impact on line efficiency, as research they have done across the industry indicates impacts of 30-40%, although much of this can be recovered as operators become familiar with the new technologies and processes.

Track and Trace implementation and Merck’s “CMO onboarding programme”
Gert Vieugels, Global Program Manager, Track and Trace, Merck KGaA
Gert’s presentation covered the work that Merck is doing to implement Serialisation, particularly in their CMOs.

From 2011 to 2014 there were 264 product issues reported through Corporate Security in Merck and thus this programme is seen as a key part of assuring patient safety.  Through current known legislative requirements, 75-80% of all Merck SKUs will have to be serialised by 2019.

The Serialisation programme is part of an overall product security strategy and was launched in late 2013.  Roll-out is planned to be complete in 2018.  Scope includes all Merck facilities and CMOs.  A cross-functional Steering Team and Programme Team is in place.  Whilst seen as a compliance programme, it is also seen as a platform for brand protection, patient support and information provision.

30 internal lines are now complete with a further 35 to go.  70 CMOs need to be integrated before 2019.  Implementation in CMOs will be challenging due to differing IT systems, levels of knowledge in CMOs and contractual obligations.  System integration will be via TraceLink and serialisation numbers will be managed and provided by Merck.  The CMO stream is working on assessing status with CMOs, educating and developing integration templates.  They are also working on risk mitigation strategies and pruning of the CMO supply base.  CMOs need to be prepared for Serialisation if they want to remain as suppliers.

There is a wide variation in the level of preparation and maturity across the CMOs, with many reluctant to do anything until they get clear messages from their customers.  Implementation takes time and so CMOs need to be careful that they ensure they have time for installing required equipment and implement required changes to processes.

Regulations, Requirements and Standards for Europe
Philip James-Bailey, Industry Development Manager, GS1 UK Healthcare
Philip presented on GS1’s activities in setting standards and building partnerships for coding solutions.  He explained the requirements of the EU FMD legislation and the GS1 global system of standards – how barcodes are constructed and what content is held in each.  For FMD, barcodes need to hold the product code, serial number, batch number and expiry date in the code.

The GS1 system provides benefit by providing a set of standards across the value chain to the patient.

Developing a Serialisation Strategy
Stephen McIndoe, VP, Be4ward Ltd
Stephen presented an overview of serialisation requirements and what a CMO would need to do to comply.  He explained the typical models for product coding, serialisation and track and trace.  He also discussed the requirements for coding and aggregation equipment to be installed on packing lines and the IT requirements to link lines to the enterprise-wide number management systems.

In a typical company many parts are impacted by new business processes and capabilities required for Serialisation.  This requires cross-functional governance and programme teams.  Change management is as important as the implementation of technologies.

He highlighted a number of implementation challenges that CMOs will face:

Many Pharma/Biotech companies are very focused on their internal Serialisation implementation and consider that their CMOs are sorting out their own programmes or have already completed for other customers.

There needs to be space on the packing components for serialisation information – for small products this could require packaging redesign

There are a number of design and implementation issues that CMOs will have to consider, and work with their customers to get appropriate decisions made that meet the needs of all parties.

Finally Stephen discussed the key elements of a serialisation strategy and how a CMO could approach developing their strategy, key learnings he has seen from numerous serialisation projects and the need to carefully select appropriate partners to ensure ongoing sustainable solutions.

Packaging Solutions – CMO specific Track and Trace packaging solutions, roll-out experience and learnings
Michel Bullen, Track and Trace Solution Manager, Optel Vision
Michel presented on the challenges a CMO will be faced with when implementation Serialisation.  He discussed the impact of the physical pack design, the need to change artwork and the impact on line operations.

He emphasised that limitations the CMO might have on print area size and location need to be discussed with customers to ensure their expectations can be addressed.  In aggregation, the limits on case sizes also needs to be discussed.

He showed a series of videos showing different solutions for printing and vision systems on both manual and automated bottle and blister lines.

Pharmaceutical Serialisation – Onboarding your CMO Network
Graham Clark, Director CDMO/3PL Business, TraceLink Inc
Graham presented on the challenges TraceLink see CMOs will have to overcome and the timelines involved.  This shows that there will be a resource crush over the next 12 months as implementation deadlines approach.

Both Pharma companies and CMOs need to consider the numbers of partners they have, the timeline to implement at any partner, the impact on down-time and production schedules and the time to change artwork.  The sequencing of all of this means that there are only so many partners you can go live with at any one time.

He also discussed the IT integration requirements between PharmaCos and CMOs to share Serialisation information.  It is not feasible to do this manually but suitable systems that can integrate to the various systems at partner sites are required.

The Seminar then broke into a number roundtable discussions around implementation challenges, risks and solutions, covering:

  • Internal/Site Serialisation programme strategy
  • Packaging Line implementations and artwork changes
  • Serialisation IT systems: Implementation and Integration
  • CMO Serialisation readiness and support strategy
  • IT connectivity/integration with CMOs and customers
  • ROI/Value beyond compliance with Track and Trace
  • Hidden challenges of Serialisation and long term code stability

We hope you find this material useful.  For more information, please contact us at enquiries@be4ward.com.

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

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My March column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ:

Ensuring effective translations – Translation memory

To read it, please click here:

We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

Posted in Articles, Artwork Auditing, Artwork Management | Tagged , | Leave a comment

2nd Anti-Counterfeiting Pharma 2016 Conference, 9 and 10 March, London

I had the opportunity to attend and chair the first day of the 2nd Anti-Counterfeiting Pharma 2016 Conference in London last week.  Many thanks to Pranita Nangia, Jasneet Gulshan and the team at Recunnect for organising the event.

Presentations from Day 1 of the event were:

Comparing European, US and Middle East counterfeit markets

Bawan Ahmed, Senior Pharmaceutical Assessor, Kurdistan Medical Control Agency

Bawan presented on the counterfeit market in Iraq in comparison to the rest of Middle East, Europe and the US.  The Kurdistan region is an autonomous part of Iraq and has its own Medical Control Agency.  There are 500 registered pharmacies and 6000 unregistered pharmacies which is an outcome of the many years of sanctions against Iraq.  This informal supply base is uncontrolled, with pharmaceutical product being sold in market stalls, shops and even butchers!  Product may be manufactured locally or imported and is shipped around the region in taxis.

Bawan and his team are seeing around 1000 cases of counterfeit medicines a year but with only 5 staff in a dangerous and fluid environment, it’s difficult to police.  The situation is improving through greater collaboration between enforcement parties and the pharmaceutical companies and improved training of staff.

GS1 Standards – a tool to combat counterfeiting?

Glen Hodgson, Head of Healthcare, GS1 UK

Glen discussed the GS1 standards and how they can help combat counterfeiting.  GS1 standards underpin most serialisation and authentication solutions.  He explained the requirements of authentication and traceability, gave an overview of the overall responses from Interpol, WHO and WCO and outlined GS1’s involvement in the Joint Initiatives Council which is shaping solutions to the counterfeit drug challenge.

Tamper Evidence Implementation in Packaging Lines

Andreas Brandt, Business Development Manager, Baumer HHS GmbH

Andreas presented on the other main aspect of FMD – tamper evidence.  He explained the solutions that are available and issues to consider when selecting tamper evidence solutions.  He showed the various examples of tamper evident solutions and focussed on the types of glue solutions.  Using a combination of hot melt and cold glue gives the benefit of quick adhesion but without the risk of re-opening that you get with hot melt only.

Andreas highlighted that all products must have tamper evident features applied by 2019.  The lead-time to get new tamper evidence equipment installed and products produced is short so it is an issue that needs to be addressed soon.

2D Barcodes: Implications on Branding, Patients and Anti-counterfeiting

Aaron Barzey, CEO, ADB Medical

Aaron discussed some of the recent counterfeit issues that have happened around the world.  He explained some of the different coding solutions and in particular the use of QR codes in Europe and the US.  He also discussed some other types of covert and overt brand protection solutions, for example micro-taggants applied to the drug product.

Challenges of Serialisation and Track and Trace applications on a company level

Michael Urso, Product Manager Pharma & Packaging Solutions, Atlantic Zeiser GmbH

Michael presented on the concerns about serialisation that they have seen at various clients in the projects they have been involved in.  He gave an overview of different options for incorporating the equipment necessary for serialisation into packing lines.  He also discussed the architecture options for the level 3 and 4 systems that can be required and the impacts of managing number allocation to multiple locations and packing lines. 

Anti-counterfeiting Technology – An investment not a cost

John McKeon, Technical Director, Portalis Ltd

John outlined the capabilities that Portalis have developed to help companies implement serialisation solutions.  He discussed the various components of a packing line that are impacted by serialisation and how to ensure these requirements were built-in in a cost effective way.  Understanding the overall architecture is critical to ensure that data flows between Level 1 and Level 4 as necessary.  There are many variations possible, but the cheapest solution is not necessarily the most appropriate.

Strategies to mitigate risk in the supply chain

Elizabeth Haveman, Director, Anti-counterfeiting, Global Product Protection, Abbott

Elizabeth’s presentation covered the activities Abbott undertake globally to address the threat of counterfeit products.  Presented as a list of 20 tips she covered topics including what to do to monitor activities in markets and across the supply chain, management of external partners, laboratory capabilities required, influencing and engagement with authorities, and use of anti-counterfeiting technologies.  She gave examples of some of these activities in use and the benefits delivered to Abbott.

Towards the digitisation of pharmaceuticals

Prof. Lee Cronin, Regius Chair of Chemistry, School of Chemistry, University of Glasgow

The subject of Lee’s presentation was the vision of being able to create chemical entities automatically from code rather than through traditional chemical processing.  Drawing parallels to digital printing where objects can be created from a digital instruction using standard machinery and building blocks, he discussed a future where standard chemical processing machines could take base materials and through a standardised digitised methodology or recipe, could create chemical and pharmaceutical entities.

Whilst this technology is some way in the future he explained some of the development work being executed under his stewardship to develop conceptual and prototype machines.

Understanding Global Regulatory Laws

Ewan Townsend, Associate, Arnold & Porter (UK) LLP

Ewan discussed the development of the legal framework for pharmaceutical regulation, as legislation evolved from numerous significant patient safety events, and leading to the Directives seen in the EU today.  From this, he showed how this has resulted in numerous and sometimes inconsistent laws regarding counterfeit medicines around the world that have had to incorporate the views of many different stakeholders.  This slows progress and requires much cooperation between partners.

He also discussed some potential future trends:

  • Porous borders where there is a difference in price
  • Targets will diversify to where enforcement is low if organised crime still manages to make high margins
  • Increased global cooperation and a harmonisation to global responses and solutions
  • Increased involvement of charities and philanthropists in driving for solutions

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

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Why design and controls are important for your Artwork Program?

We discussed in my previous blog Technical Errors vs Human Errors with labelling and artwork-important you treat them differently,  the main differences in dealing with errors created by humans and technology. Another source of error can be attributed to the lack of robustness or effective control points in your artwork process.

The categories of errors that can result from poor process definition and controls include:

Gaps and inconsistencies in the process

As its name suggests, these errors occur when the design of the business process is incomplete or conflicting. A common problem is where the provision of a particular piece of information is not well defined. An error of conflict is where there is a shared market pack and a change proposed by one market is made but the other market approver is missed off approving the change.  An example of an incomplete process is where the safety compliance team have not been included in the ‘loop’ for an existing product and the text does not include the latest safety data.

Insufficient competence

The same way, if the definition of the process is not well established, it can lead operators not to have the right set of skills and knowledge to perform the tasks required. An area of particular concern is where people are trained in a task but are required to do it infrequently. An example is where personnel in the affiliates are asked to approve artwork in a workflow package which they only use every few months. In these circumstances, it is key is for them to be able to refer to a procedure with easy to follow instructions.

Not enough of quality time

On a similar note, if time allowed to do the task in the process is constricted, this can lead to errors. An example would be when the time agreed for the proof reading step is squeezed. Proof reading, when done properly, must be performed in a quiet well lit room, free from interruptions and the time allotted must be allowed if you want a quality result.

Ambiguity

Previously we have talked about the role of ambiguity in causing errors. An example would be where the market’s requirements for a change have not been well specified, resulting in the artwork operator misinterpreting the information and the artwork has to be redone, causing delays. It is important the market’s instructions are not sent via imprecise methods like emails or voicemails but captured in a formal process with no room for confusion.

Process definition and control are, among others, key components in building up artwork capabilities and reduce, as much as possible, the level of errors. The care and consideration given to this step in creating the artwork processes will help you maintain a certain quality level.

After reviewing the main causes of errors, we will focus our next topic on the consequences of errors on company operations.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment

Technical errors versus human errors with labelling and artwork- important you treat them differently

In my previous blog post, Working with your external partners to ensure an effective response to an artwork related drug recall, I talked about the significance and impact of labeling and artwork errors in your company. In this blog I discuss the importance of recognising you need to respond to the type of errors differently and how you might future proof your process to make such errors much less likely.

When performing an audit of your current process it is important to root cause the type of mistakes made and determine if they are caused by human error or caused by technical problems.

Artwork errors caused by humans versus technical ‘machine’ issues

Root causing errors in your process will almost certainly give you some common failings. A classic human error example is misinterpretation of the requirements of an artwork change where the end result is not what the person had intended when they gave their input.  Another example would be where the leaflet artwork has been checked but not proof read correctly or perhaps a proof reading step has not been included and the text is incorrect.

A technical error example would be where a work flow software package has been utilised but a system error has caused the wrong version of the file to be used. Another technical issue could be where proof reading software has caused an error by lacking the functionality to read text embedded in illustrations, but users not being aware of that limitation.

When future proofing your process or responding to existing issues – how you might respond?

With technical issues it is important to recognise that software packages come with limitations, so it’s critical to understand these from your vendor and put in extra checks as required. Software validation is key to verify the system works as intended and should pick up configuration and functionality errors before implementation.

Regarding human issues there are three things to consider:

  1. Remove the ambiguity factor by introducing standard processes with checklists to remove the potential for interpretation and ensure you comprehensively train everyone in those processes. Key when designing the process is identifying the high risk areas and putting in robust steps.
  2. Address the lack of discipline factor – consider that some errors are caused by people not following the process for various reasons and embed controls to ensure the process is followed with rigour.
  3. Recognise the limitations of the human brain which has a tendency to ‘fill in the gaps’ when reviewing text and support them with effective proof reading processes, training, checklists and tools.

In the next blog we will be considering this topic further with some more insights into the designs and controls in your artwork process.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment

Working with your external partners to ensure an effective response to an artwork related drug recall

Pharmaceutical supply chains are becoming ever more complex, involving an increasing number of external partners.  This week, I want to speak about the external partners that might be involved in an artwork related drug recall and how pharma organisations can work effectively with them to minimise the risks involved.  We saw in the last Artwork 101 post the main actions to do when the error has been spotted externally to the company. The implications of an artwork error can be as far-reaching and serious as any other error with the supplied product.  In a recall situation you will likely have to work with a range of external partners to carry out the corrective actions required to recall the product and resupply the market and the preventative actions required to address the root causes of the failure.

There are a number of external partners involved who have unique roles to play

Joint ventures, local external marketing companies and local distributors: Many pharmaceutical companies work with local partners in different countries around the world to market their product in that local country.  In a recall situation, these local companies may be the main point of contact to the impacted customers in that local market and also to the local Health Authority.  Therefore they have a key role in maintaining relationships with customers and regulators.  Your company is likely to have well defined recall processes that would be invoked for an artwork related error and these local partners will have communication roles to play within these processes.

Artworks will need to be updated to resupply the market and these local partners will likely have to be involved in definition and approval of these new artworks.

When assessing the root causes of the incident and the preventative actions required, the end-to-end process for artwork definition and approval through these external parties must be considered.  How robust are these processes and how well have you trained your partners?

Wholesalers and Distribution partners: These are the operations that move product through your supply chains.  They will be involved in the corrective actions, quarantining and returning product and supplying new product to the market.  Again this should be through your company’s standard recall and resupply processes.

Contract Packaging Operations and Printed Packaging Suppliers:  Most pharmaceutical companies use external partners to manufacture packaging materials and to pack product.  Like the above, these partners will be involved in recalling and resupplying the market, quarantining incorrect packaging materials and packed product in their inventories, manufacturing new packaging materials and repacking impacted product where feasible.  They will also be involved in the approval and quality control of the artwork on the resupplied packaging materials.

The end-to-end process again needs to be reviewed when assessing root causes to ensure the effectiveness of the artwork process steps undertaken by these partners.

External Graphics/Artwork providers: You may use external agencies for artwork creation.  Revised artworks will be required and likely with some urgency.  You need to ensure that rigor is maintained to avoid errors occurring when people are in a rush situation.  As with the previous partners, assess the end-to-end process through these artwork partners to ensure that the root causes of the error are identified.

Clear processes that are well understood by your partners

A recall is an event that any pharma company wants to avoid.  It risks the well-being of the patient, places a burden on healthcare providers and causes unnecessary disruption to customers.  However mistakes do happen and therefore it is essential to ensure that there are clear effective processes across the extended supply chain to manage the recall, revise the artwork, resupply the market and ensure that the root cause of the error is eliminated so it is prevented from happening again.  Working closely with your external partners is key in ensuring a controlled outcome.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment