pharmaceutical packaging & labelling … packaging & labelling insights top tips for 2015...

PHARMACEUTICAL PACKAGING &

LABELLING INSIGHTSTOP TIPS FOR 2015

www.pharmapackaginglabelling.com/?mac=PMIQ

THE BIGGEST BARRIER TO ACHIEVING EXCELLENCE IN PACKAGING AND LABELLING IS…?

Pharmaceutical packaging and labelling continues to rise up the agenda. As pharmaceuticals come under greater regulatory scrutiny, companies have to evaluate

their packaging and labelling processes to ensure compliance and reduce risk. Being able to provide a cost-efficient, optimised packaging line has become the top priority for manufacturers. Ahead of the Packaging and Labelling Summit 2015, Pharma IQ asked key speakers and leading stakeholders from the industry to reveal the biggest obstacles

they face in achieving excellence in packaging and labelling and reveal their top tips for an effective packaging and labelling strategy and process.

“A lack of consideration and understanding of the patient’s needs, coupled with a lack of data that

demonstrates ROI for patient friendly

features.”Phill Marley, Packaging

Intelligence, AstraZeneca

The pursuit of excellence is a never ending journey, also because the world is in constant change. Keeping on the path of this change is key.”

Carolina Sanchez Cespedes, Head of Packaging, Lilly SA

“The conflicting demands of the many different stakeholders involved in the specification and use of packaging. Cost effective vs eye-catching, easy to open vs child proof, innovative vs able to run on

existing machinery.”Andrew Love, Vice President Capability

Development, Be4ward Ltd


“Poor alignment within an organisation on the requirements development prior to implementing changes. So many times we see companies rush into a program on Label changes but without the

requirements developed correctly. This almost 100% of the time leads to failure, budget & time overruns.”

Greg Cathcart, CEO, Excellis Health Solutions

“Cost. There are many excellent materials and tools out there that pharma simply does not

choose due to cost. The second related to this is disconnect with

outcome. If pharma supplier had responsibility for patient

outcomes with their product you would see dramatically different packaging than we have today.”

Walt Berghahn, Executive Director, Healthcare Compliance

Packaging Council (HCPC)

“A combination of fear and costs. Ideas are not taken further if there is any doubt that a detail of labelling might cause discussions with the competent authorities, or if there is any doubt that labelling is not the very cheapest available. The

pharmaceutical industry is scared to discuss ‘legal compliance’ or

‘financial investments’.

In order to overcome this barrier, it is essential to apply a standard

design process in which all stakeholders are encouraged to

participate. It simply means that it is essential to establish a cooperation

between industry, regulators, and patients. It is very likely that such a cooperation will show that it is possible, within the current

regulatory framework, to develop packaging and labelling that really supports the activities of people”.

Dr Karel van der Waarde, Pharmaceutical Consultant and

Graphic Design Researcher

“First of all, we have to recognise that the first challenge is the human

being, in terms of change management. We are facing a lot of change in terms of using new tools and new

ways of working, but the real challenge is to get people to

understand the new value that we can create having embraced the change and use our way of working.”

Gianluca Fioravanti, Head of Packaging &

Warehouse Operations, GSK


WHAT KEY TRENDS ARE YOU WITNESSING IN PHARMACEUTICAL PACKAGING AND LABELLING…?

“Tremendous movement in the emergence of

serialisation requirements, (EU FMD, US DQSA etc.).”

Phill Marley, Packaging Intelligence, AstraZeneca

“An increased focus on Brand Protection beyond serialisation and authentication. Increasing usage of compliance packaging to improve

adherence. The emergence of smart packaging solutions to provide

solutions to both of the prior trends”

Andrew Love, Vice President Capability Development, Be4ward Ltd

“The key trend is that the basic needs of patients get less and less attention. Since the introduction of the European legislation in 1992, the needs of patients to take medicines

appropriately have been increasingly ignored. A combination of strict legislation and strict budget control makes it close to

impossible to provide patients with the packaging and labelling they expect. At a point in the near future, patients won’t be able

to open their medicine packs anymore (= ‘tamper evident’), can’t understand the instructions (= ‘readable’), and can’t take

their medicines correctly (= ‘compliance’).

If we reverse this trend, we would make packaging where opening is not even an issue for patients, where the instructions

and warnings are integrated in a communication strategy in which industry, doctors, pharmacists, and patients cooperate,

and where it is nearly self-evident how to take and combine medicines into daily routines of patients.”

Dr Karel van der Waarde, Pharmaceutical Consultant and Graphic Design Researcher

“The most impactful trend is globalisation. Products are becoming available to more global markets and in turn, these markets are developing individualised regulatory strategies.

This creates challenging requirements for labelling and packaging. Many initiatives, such as UDI and track & trace are

now being implemented and requirements are not globally harmonised. This requires companies to develop different

labeling and packaging strategies to address individual country requirements that can result in expensive and time consuming

projects to ensure compliance. Regulatory intelligence processes look to be the key - companies with the ability to

look forward, anticipate and plan these changes to be proactive rather than reactive can make the labeling/packaging change

process less chaotic and more systematic, saving time, costs and resources.”

Dawn Fowler, Senior Manager, Document Control & Global Labelling, Endologix

“I think everyone has been so focused on DQSA that other

trends have been overshadowed. Certainly there are some interesting

developments in materials. Packages are becoming more functional but at a slow pace.”

Walt Berghahn, Executive Director, Healthcare Compliance Packaging

Council (HCPC)

“The two biggest trends we are tracking are the Serialisation packaging/labelling changes as well as the FDA guidance on elimination of Product Inserts. Once this is approved it will mean a large amount

of change in organisations.”


“More focus on the individual patient needs, from their

compliance to the treatment, the protection against falsified

product, to the readability of the patient information as well as

the increasing length of it.”



MY TOP TIP FOR AN EFFECTIVE PACKAGING AND LABELLING STRATEGY IS…

“Ensure that the pack needs of the patient are built into the final pack

as soon as possible in the development process,

including pack user trials if possible.)”


“Make sure you take a holistic approach covering all of the

aspects of packaging operations in your company and involving all

of the impacted stakeholders.”

Andrew Love, Vice President Capability Development,

Be4ward Ltd

“As a first step, it is essential to really adhere to the current legislation, involve all relevant stakeholders, and

focus on a patient-centered approach. A second step would be the modifications of the regulatory framework

to optimally support performance based design.

Start from the perspective of patients to enable them to take medicines correctly. This means that the legislation must allow for a substantial variation because different patients see different medicines in different contexts.

[There are fundamental differences between oral contraceptives, injectable insulin, a painkiller, and

NRTIs. They are used in different circumstances, for different reasons, and by different patients. At the

moment the labelling of these products must adhere to the same legislation and the labelling of all four looks nearly identical …] It’s not possible to make ‘1 standard

package with 1 standard label’ that suits all patients across Europe.

Not all medicines and all patients and all circumstances are identical across Europe. If we really want to make packaging and labelling effective, than we must take these differences into account. Or even stronger, we

must start from these differences to make sure that we really ‘enable people to act appropriately’.

So, my top tip is: Just apply the existing legislation and ‘enable people to act appropriately’. That has been the law since 2004, and only very few - if any - medicines

adhere to this.”


“Focus on the real customer, the patient. Manufacturers today create packages that work well for distribution because they know their package is unlikely to

reach the patient, it will be tossed away in the pharmacy. If they were to create patient ready packaging it will survive

the pharmacy and increase supply chain security at the same time!”

Walt Berghahn, Executive Director, Healthcare Compliance Packaging

Council (HCPC)

“Plan it out effectively, develop your URS and use the URS as the foundation

to what you’re trying to accomplish.”


“Agility for change and a forward vision of the

changes to come.”



MY TOP TIP FOR OPTIMISING THE PACKAGING AND LABELLING PROCESS IS…

“Close collaborative working between all of your functions,

so each can understand the needs of the other e.g.

manufacturing and commercial; regulatory and patient groups.”


“Make sure the requirements are clearly agreed up front before entering into multiple wasteful cycles of redesign.”

Andrew Love, Vice President Capability Development, Be4ward Ltd

“The top tip is that there is no standard approach, and no ‘best labelling process’. Some industries focus

on the profit margin only, some focus on the legal boundaries, and some focus on the needs of patients.

It really depends on the aims that need to be met which processes are most suitable.

One way to allow for these different approaches, which are all valid, is to develop ‘performance based legislation’. This would make it possible for all sorts of approaches to fall within the legislation. The main

point is that it would make it possible for really ‘patient centered industries’ to make stunningly beautiful,

usable, understandable, and attractive packaging and labelling. At the moment, the legislation/guidelines/

templates make any effort into this direction a frustrating and time consuming experience. And still, there are many companies who want to go this way.”


“When trying to optimise your Tamper Evidence solution, try to pick a solution that is most cost effective, easy to

implement, and easy to open by the users/patients. Coming up with the solution itself is not the issue, but implementing it when you have different contract manufacturers, that will

have their own solution is the biggest problem that most companies will face in the coming stage of implementing the Tamper Evidence on their packages. Therefore you must start

now to find the best solution on the market, and present it your contact manufacturer, to save your cooperate identity.”

Hussein Al-Qasim, Serialisation & Tamper Evidence Project Manager, Genericon

[In terms of overcoming complexity in the process] “The main point is to try to harmonise as much as possible all the components in terms of leaflets, in

terms of custom box, in terms of bottles. And these initiatives and projects help us to minimise the

impact of complexity but complexity is something that we are going to always deal with and we

have to just minimise what we can do in terms of harmonisation.”

We are working a lot bringing on the shop floor the way of deciding and improving the process.

So to improve our performances, first of all, we are putting the operator in the middle of the decision-

making to find the best way to solve root causes and implement corrective action. We are using several

tools to do this but without the proper engagement of the personnel, this would not be useful.”

Gianluca Fioravanti, Head of Packaging & Warehouse Operations, GSK

“Focus on understanding the future demands on package & label

requirements and use those demands to build out a plan to achieve.”


“Flexibility and a good combination of automation, integration and human creativity.”



Streamline Packaging Processes, Increase Patient Safety and Ensure Compliance

Packaging and Labelling 2015 is an industry led event with expert speakers across pharma, biotech, and influential

associations such as EFPIA, EGA and GS1.

Europe’s most senior-level industry-led packaging event brings pharmaceutical leaders from all functional groups across packaging, serialisation, artwork and

labelling to Basel for three influential days of hard-hitting discussions.

At the 2015 Pharmaceutical Packaging and Labelling Summit, engage in strategic discussions with packaging experts from Eli Lilly, GlaxoSmithKline, Roche,

AstraZeneca, Abbott and Bayer and gain expert knowledge on best practice for new programme and technology implementation.

For more informationGo to: www.pharmapackaginglabelling.com Email: [email protected] or Phone: +44 (0) 207 036 1300

Want to find out more? Hear directly from these experts and more: Carolina Sanchez Cespedes, Head of Packaging, Lilly SA on Creating a High Performance, Cost Effective Packaging Line: Best Practice Approaches to Achieving Excellence

Gianluca Fioravanti, Head of Packaging and Warehouse Operations, GlaxoSmithKline on Ensuring Operational Excellence and Increased Efficiency of Packaging Lines with a Robust Design

Marcel Zutter, Global Programme Manager Serialisation, Abbott on Ensuring Effective Implementation of Serialisation

Phill Marley, Packaging Intelligence, AstraZeneca on Ensuring Patient Compliance via Packaging Design

Hussein Al-Qasim, Serialisation & Tamper Evidence Project Manager, Genericon on Examining Standards for Incorporating Tamper-Evident Features in Packaging


http://www.pharmapackaginglabelling.com/media/1000496/1000496_Brochure.pdf

pharmaceutical packaging & labelling … packaging & labelling insights top tips for 2015...

Documents