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Serialization for late starters 1
Serialization for late starters ebook
Serialization for late starters 2
Introduction
In an industry as vast as the pharmaceutical market every company is at a different stage of implementing serialization to ensure complete compliance when new EU and US regulations come into force.
Due to the challenge of introducing a robust serialization solution, many companies are now experiencing unforeseen issues as the industry starts to recognise the magnitude of the task at hand.
For those that have delayed developing their serialization strategy, adopting a ‘wait and see’ approach, time is quickly becoming a concern as the US deadline in November 2017 approaches, followed closely by the EU regulations in 2019.
This e-book is designed to give companies just starting out on their serialization journey, as well as those that are already some way along, a guide to the various complexities associated with global track and trace requirements.
Serialization for late starters 3
What is serialization and why do I need to do it?
During recent years, the pharmaceutical industry and regulatory authorities have placed increasing importance on the worldwide issue of falsified medicines entering the supply chain. According to the World Health Organisation (WHO) around 15% of all medicines are counterfeit.
Counterfeit medicines not only pose a significant risk to patient health, but also cost the industry money, with the falsified medicines market worth over $75million per year. Doubt surrounding the integrity of the supply chain can also severely damage the reputation of manufacturers and distributors.
By 2019 over 55 countries will have introduced serialization and track and trace compliance laws in order to follow the passage of pharmaceutical products throughout the supply chain and combat the growing problems surrounding counterfeit drugs, reimbursement fraud and product theft.
The implementation of serialization and track and trace systems is a challenging process and with the requirements, just around the corner, it is imperative that pharmaceutical companies act now if they haven’t already started implementing a strategy.
Serialization takes place at unit level.
Serialized units packed into case. Case is then serialized if required and first level of aggregation takes place.
Serialized cases packed into pallet. Pallet is then serialized if required and second level of aggregation takes place.
Serialization for late starters 4
Understanding the benefits of pharmaceutical serialization.
On the surface, serialization may appear to be a relatively simple addition to production lines; a barcode or serial number must be added to every saleable drug unit. Simple, right? Varying regulations across numerous markets and the huge amount of data produced means there is more to implementing serialization than first meets the eye.
Patient safety
Delivering patient confidence in medicines.
Protecting patients against counterfeit products.
Supply chain security
Improving visibility across the supply chain.
Tightening controls around:
•Theft
•Illegal diversion
•Unregistered product
Financial benefits
Reducing the potential for reimbursement fraud by linking the serial number to reimbursement systems.
Reduce the amount of product which is illegal and does not generate tax revenue.
Efficiencies and standardisation
Improve the operation of the supply chain by using the new data and barcodes on the product.
Working with GS1 or other standards to optimise the way healthcare is delivered globally.
Serialization for late starters 5
Who needs to be involved?
Operations
EngineeringProcurement
Quality
IT
Packaging linesand production
department
Marketing
With so many different facets to serialization, it’s important that as many stakeholders as possible understand your approach and the size of the task at hand. The more you involve each department within your organisation, the easier it will be to overcome any potential hurdles and the more successful your implementation process will be.
Serialization for late starters 6
How do the global regulations differ?
One of the biggest hurdles for pharmaceutical companies is the global environment they operate in. One company can be responsible for the manufacture and distribution of drug products in numerous markets, and with no two countries passing the exact same compliance laws, they are faced with the challenge of implementing a solution that caters for lots of different regulations.
For example, while the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) require a randomised serial number to be produced and incorporated into a GS1 barcode, the Chinese market requires a linear barcode using a number allocated by the government prior to production.
The scope of medicines covered by serialization rules also varies from country to country, for example South Korea’s track and trace requirements extend to over-the-counter (OTC) medications, as well as prescription drugs. With these variations in mind it’s important to consider all the markets you operate in, or that you might enter in the future.
Aggregation requirements also differ depending on the country the pharmaceutical products will be distributed in. The EU FMD only requires serialization at unit level, however South Korea and India have made serialization mandatory on primary, secondary and tertiary packaging. This means companies supplying to these markets must ensure their serialization systems are able to to record parent-child relationships between each of the packaging levels. In many cases, it is sometimes better to incorporate aggregation as part of your standard solution as it can also help to speed up a product’s journey through the supply chain by minimising the need to unpack batches.
It’s here that bringing in outside expertise can be of real benefit. Previous experience and knowledge of the serialization landscape is invaluable when developing a robust strategy and with time constraints getting tighter and tighter, expert knowledge can really simplify up the process of developing an effective solution.
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What are the technical considerations?
When it comes to technical requirements, serialization can be a minefield so making the right decision when selecting hardware, software and cloud providers is absolutely vital.
There is no one size fits all solution and given the extensive scope of serialization, a comprehensive strategy will most likely involve multiple vendors working in collaboration. So, where do you start?
Packaging
Data storageCodes
Your first consideration should be your packaging requirements. The addition of a barcode might mean you need to redesign your packaging, in which case you need to build in time for this process. A lot of serialization legislation also requires packaging to include tamper evidence and if you’re supplying to markets which do, you will need to integrate this into the design as well.
As the type of codes required varies from market to market, this can have an impact on the print technique used. In all markets the barcodes need to be machine readable, making print quality a critical factor to avoid rejections and loss of stock. High density codes, for example the GS1 barcodes used in multiple markets, will require the quality finish associated with thermal inkjet or laser printing. If you’re supplying to markets with different requirements, opting for a higher print quality as standard is a more time and cost effective approach.
Once you have determined your requirements and chosen appropriate hardware and software providers to serialise your products and perform any aggregation, you need to consider how you’re going to store all this new data. The simplest solution is an external cloud storage provider, but it is essential to ensure they can support the transfer of sensitive date between third parties and store your data securely for the required length of time.
Data integrity is paramount so doing your research, or seeking the advice of a third party with experience of implementing successful serialization programmes, is recommended.
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The various complexities associated with implementing serialization are vast, so you need to build time into your strategy to do test runs on a pilot line to avoid costly mistakes come the deadline.
The US DSCSA comes into force in a matter of months and with so much to consider, companies that haven’t started to implement serialization solutions should look to bring in third party expertise to speed up the process. Failing to meet upcoming deadlines could mean disruption to product supply, costly downtime and an impact on your reputation.
Zenith Technologies and SEA Vision have successfully managed global serialization projects in Asia, the US and Europe, with an average implementation schedule of just ten weeks. Using their expertise and proven methodology, the team can offer seamless implementation of new processes and technologies across multiple sites and ongoing support.
How do I get started quickly?
Disruption to product supply
Costly downtime
Impact on reputation
Serialization for late starters 9
Timeline from start to finish
7 weeks for total installation including 2 weeks of scheduled downtime (average)
3 weeks for total installation including 1 week of scheduled downtime (average)
02 04 03
02 01 01
Site kick off meeting and information gathering. Preparation work.
Documentation and IT set up.
Server, first line pre installation & testing.
First line installation and test.
First line operational qualification.
days weeks weeks
weeks week week
Server and first line
01 01
02 03
Documentation and IT set up.
Line installation and test.
Operational qualification.
week
days days
Subsequent lines
week
Server, line pre installation & testing.
Serialization for late starters 10
Top Tips Five steps to success
Have you already started implementing your serialization strategy?
Here’s our five steps to success.
0102
0304
05
Be forward-thinking
The likelihood is that as serialization becomes the ‘norm’ in the pharmaceutical industry, regulatory bodies will identify ways to make anti-counterfeiting measures even more robust. So, consider how your serialization solution will stand up to changes in regulation. Ensuring you have a flexible solution from the outset will make it easier to adapt as legislation
evolves over time.
Market requirements
Many pharmaceutical manufacturers will supply to multiple markets in a number of geographic locations, all of which have slightly different track and trace compliance laws. Again, the flexibility of your solution is key. Get to know the varying market requirements and consider whether your solution can adapt
to them all.
Build in time to test your solution
On paper your serialization strategy may appear robust, but there’s no substitute for rigorous testing. Testing your solution out on a pilot line will allow you to identify potential hurdles before they arise and avoid costly downtime, loss of business in key markets, product wastage and
even supply shortages.
Ensure your staff are ready for the challenge
Integrating serialization into your supply chain should extend beyond the hardware and software requirements. With so many facets of serialization to consider it’s important that your entire team understand their role in compliance and how your solution will affect every part of your organisation. Investing time in training your staff will be invaluable when it comes to overcoming problems and avoiding
unnecessary expense.
It’s not too late to consider support
Serialization is a complex process and even if you’ve already started to develop a strategy, bringing in external expertise can help to speed up your journey and simplify the integration of new technologies. Don’t take a short-term view. While the end goal of achieving compliance before the US and EU deadlines is important, a robust support model should be in place for
the long term.
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Contact
Carlos Machado is serialization director at Zenith Technologies and is responsible for sales, operations, implementation and post project support services in the US and Canada. As part of the serialization initiatives, Carlos is leading the partnership between Zenith Technologies and Sea Vision implementing its serialization product suite, focusing on speed to deliver, engineering excellence and a superior customer experience.
In his previous role as director of operations at a leading anti-counterfeiting technology provider, Carlos helped to pioneer the serialization concept and define the future of authentication.
He has a wealth of experience in assisting pharmaceutical manufacturers with track and trace technologies and has worked on more than 75 serialization projects, from both an operations and delivery perspective.
Marco Baietti is commercial director at SEA Vision with responsibility for technical sales and advising pharmaceutical and biotechnology clients globally on the introduction of serialization software.
With 20 years’ experience in technical sales, Marco has the ability to understand clients’ complex challenges and find a solution to meet their needs. Before joining SEA Vision, Marco worked for a number of leading global companies in packaging machinery. Marco has a BA in Electronic Engineering, Management Information Systems and Services.
Carlos MachadoSerialization DirectorZenith Technologies
Marco BaiettiCommercial DirectorSEA Vision
SEA Vision+39 0382 529576
www.seavision-usa.com
Zenith Technologies+1 61 02 34 32 42
www.zenithtechnologies.com
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Serialization for late starters 12
SEA Vision+39 0382 [email protected]
Zenith Technologies+1 61 02 34 32 [email protected]
