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Pharmaceutical Pack Management – finding a home

As discussed in our previous article, Pack Management is a critical function that touches multiple stakeholders and departments. Regulatory Affairs, Supply Chain, Production, QC and QA are all significant process stakeholders, but Medical, Legal, Commercial and other departments may be contributors or have pack management dependencies in their own processes too. With pack management impacting so many disciplines, internally resolving ownership of the function can often be challenging but it is a decision that if well-made can reap significant benefits.

It must appear tempting, particularly for smaller companies, to consider moving responsibility for product pack management and labelling artwork almost entirely to the manufacturing site, whether they be ‘in-house’ or contracted. This approach can indeed be attractive and may be perceived as effective for the first product launch or when only one or two manufacturing sites support a company’s product portfolio.

However with expansion comes complexity and additional management challenges. The quick fix of moving responsibility to the CMO may no longer feel so wise. You may now have the need to manage multiple labelling change controls across two or more suppliers, who likely have different approaches or processes. Grasping the nettle and having a single function – internal or outsourced – working to a consistent process and responsible directly to and liaising with all process stakeholders, can provide significant advantage in terms of demonstrable control, efficiency and cost. But in which functional group does it find the best fit? Here’s a summary of the favourite options;

Regulatory Affairs – a common home for pack management and the origination point for the SmPC, registered text and all non-technical content that appears on a component artwork. Regulatory Affairs are also the source for change implementation constraints, being the main conduit between the company and the regulatory authorities. However as a medical department, interaction with supply chain and manufacturing functions is less common, as is exposure to the daily rigours of GMP.

Quality – fundamentally, the role of ensuring that a product is manufactured in compliance with regulatory requirements and according to Good Manufacturing Practice (GMP) standards falls to the Quality function in a pharmaceutical company. As it is a cross-functional department with close interaction with Regulatory Affairs, Supply Chain and the production sites, the case can be made that the Quality Assurance department is the ideal candidate to deliver the pack management role. However, one of the main responsibilities of the QA department is to remain an independent reviewer and approver with respect to manufacturing and process/ product development units. It could therefore be seen as a conflict of interest between their regulatory responsibilities and their actual daily activities.

Production – With a primary responsibility for manufacturing product that is fit for purpose, the production facility often provides a home for pack management. When sitting within the manufacturing site, pack management departments are close to the eventual point of need, well aware of the demands and lead-times of the facility. For companies with small product portfolios manufactured at one facility, locating packaging artwork change control activities within an environment already versed in GMP can be extremely effective. For large multinationals too, with networks of facilities across the globe, an integrated international pack management organisation located at a network of production sites can provide a service that never sleeps. But manufacturing site priorities may have a different focus to regulatory affairs and other stakeholders and balancing these contrasting needs can be challenging.

Supply Chain – For many, supply chain appears the optimal pack management process owner. The supply chain team is intrinsically responsible for ensuring product is manufactured, released and delivered on time and to the right place. Artwork for packaging labelling therefore can be seen as another element of the production process and Bill of Materials to be managed. And with technical elements of information being sourced from technical operations partners and suppliers, key relationships are most easily established from this process location. However, with supply chains measured on stock availability and cost and a skillset focused on logistics and product delivery, the detailed nuances of artwork creation and pack management can be easily overlooked or not given the profile they warrant.

As can be seen, there are pros and cons for all of these potential homes for Pack Management. What does become clear is that the pack management function provides the glue that bonds several disparate departments together and requires cross-functional leadership, administration, technical knowledge and team-work to deliver compliant artwork, on-time, every time and without error. How it does that will be the subject of a later blog post.

Pinnaculum are specialists in pharmaceutical pack management services; outsourced administration, artwork creation, technology and optimised process design. If you would like to know more of how we help companies deliver world class pack management that makes a difference to their reputation and balance sheet, visit our website or give our offices a call.

Mark Wilkinson
Pinnaculum Ltd
www.pinnaculum.co.uk
mark.wilkinson@pinnaculum.co.uk
0044 1438 791111

Pharmaceutical Pack Management - why is it important?

Pharma Pack Management, artwork administration, artwork co-ordination…..whichever description you use, managing pharmaceutical labelling artwork is a pivotal function in the pharmaceutical supply chain and one that rarely gets the attention it deserves.

Performed effectively, implementing and maintaining compliant labelling for product SKUs (stock keeping units) becomes an opportunity to reduce costs, improve an organisation’s reputation for quality and differentiate them from their competitors.

But perform it badly or not at all, it can harm your patients, kill your company, trigger a product recall, delay product supply or regularly cause stock outs that directly impact the balance sheet. When errors occur, 4 main groups are impacted;

Patients

Effective medical treatment is based on trust at all levels. Patients put their trust in a health professional directly through consultation and prescription. They also place their trust in pharmaceutical companies to produce and supply them a prescribed product to the highest standards of quality and this includes the labelling. An error in the labelling can therefore not only be directly harmful – by causing a prescribing error for instance – but can also undermine the confidence a patient population has in individual drug companies.

Prescribers

There is an expectation held by all prescribers, be they pharmacists, consultants, doctors, nurses or other health care professionals that products and their labelling will be accurate, up to date, free from errors and manufactured to the highest quality standards. Aside from a prescribers trust in a company and product being damaged by labelling errors, they are also directly impacted as remedial action on their part diverts resources away from their primary function of providing health care services.

Regulators

With labelling errors identified as a significant cause of recalls, regulators are increasingly focusing audit attention on labelling change processes. With today’s technological advances providing opportunities for improved quality they are becoming less tolerant of bad practice and have the powers to take punitive action against companies not meeting expected GMP standards.

Pharmaceutical companies

At a macro level, pharmaceutical companies can be significantly harmed, both in terms of reputation and share price, by labelling errors. These indirect costs are joined by the direct costs of managing an incident. Reworking or batch and product write-offs often result, which alone can run into costs of tens of thousands. Drilling down further, the affected artwork studios and process participants will be analysing causes for the error and looking for ways to improve the process.

With its importance better understood our next article will focus on where to locate the pack management department in a pharma business.

New MHRA Blog goes live

MHRA_website_logo
The MHRA have published their first blog today, focusing on the MHRA Inspectorate and guidance and updates about MHRA inspections.
Here is a link to the site https://mhrainspectorate.blog.gov.uk/

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Health kick 'reverses cell ageing'

Going on a health kick reverses ageing at the cellular level, researchers say.

The University of California team says it has found the first evidence a strict regime of exercise, diet and meditation can have such an effect.

But experts say although the study in Lancet Oncology is intriguing, it is too early to draw any firm conclusions.

The study looked at just 35 men with prostate cancer. Those who changed their lifestyle had demonstrably younger cells in genetic terms.

Safety caps

The researchers saw visible cellular changes in the group of 10 men who switched to a vegetarian diet and stuck to a recommended timetable of exercise and stress-busting meditation and yoga.

The changes related to protective caps at the end of our chromosomes, called telomeres.

Their role is to safeguard the end of the chromosome and to prevent the loss of genetic information during cell division.


As we age and our cells divide, our telomeres get shorter - their structural integrity weakens, which can tell cells to stop dividing and die.

Researchers have been questioning whether this process might be inevitable or something that could be halted or even reversed.

The latest work by Prof Dean Ornish and colleagues suggests telomeres can be lengthened, given the right encouragement.

They measured telomere length at the beginning of their study and again after five years.

Among the 10 men with low-risk prostate cancer who made comprehensive lifestyle changes, telomere length increased significantly by an average of 10%.

In comparison, telomere length decreased by an average of 3% in the remaining 25 men who were not asked to make any lifestyle changes.

Jury's out

Shorter telomeres have been linked with a broad range of age-related diseases, including heart disease, and a variety of cancers.

I'm definitely going to wait to see whether this can be replicated on a larger scale and with more sizeable effects before I get excited” - Dr Tom Vulliamy of Queen Mary University of London


The study did not set out to check if lifestyle changes and telomere lengthening would improve cancer outcomes, but the researchers say this is something that should be investigated.

Prof Ornish said: "The implications of this relatively small pilot study may go beyond men with prostate cancer. If validated by large-scale randomised controlled trials, these comprehensive lifestyle changes may significantly reduce the risk of a wide variety of diseases and premature mortality.

"Our genes, and our telomeres, are a predisposition, but they are not necessarily our fate."

Dr Lyn Cox, a biochemistry expert at Oxford University in the UK, said it was not possible to draw any conclusions from the research, but added: "Overall, though, the findings of this paper that changes in lifestyle can have a positive effect on markers of ageing support the calls for adoption of and adherence to healthier lifestyles."

Dr Tom Vulliamy, senior lecturer in Molecular Biology at Queen Mary University of London, said: "It is really important to highlight that this is a small pilot study.

"Also, the significance of the effect of these lifestyle changes on telomere length is actually quite borderline, with only two or three men showing any improvement.

"Given this, I'm definitely going to wait to see whether this can be replicated on a larger scale and with more sizeable effects before I get excited."

Experts agree that telomere shortening is unlikely to be the sole explanation for human ageing.

For example, humans have much shorter telomeres than primates and mice, yet live for far longer.

But past work has shown that people who lead a sedentary lifestyle can experience accelerated cellular ageing in the form of more rapid shortening of their telomeres.

Telomeres

  • Sit at the end of our chromosomes
  • Likened to the tips on the end of shoe laces that stop fraying, they protect the chromosomes that house important genetic information
  • They are made up of a repetitive sequence of DNA
  • Shorten with cell divisions and can signal when a cell should die
  • If telomeres are missing, the ends of chromosomes tend to get chewed away or they may stick to other chromosomes
  • They allow the chromosomes to be replicated in their entirety

Reposted from the BBC website - http://www.bbc.co.uk/news/health-24111357

Posted by Mark Wilkinson

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Will new serialisation legislation redraw the lines in the battle against pharmaceutical counterfeiting?

The challenge of counterfeiting in the pharmaceutical industry is an ever present and constantly evolving power struggle between the pharmaceutical companies and criminal organisations who seek to profit by selling cheap, ineffective and often lethal copies of products, either through existing supply chains or over the internet.

Historically, pharma companies’ anti-counterfeiting measures have been kept secret, even within their own organisations. The less people who know the techniques being employed, the less opportunity there are for leaks. Both overt and covert approaches are used and before looking to the future, they are worth reviewing.

Overt anti-counterfeiting techniques are clearly visible on the packaging. Similar to techniques employed in the banking industry, components are designed to include graphical patterns and elements, including holographic images and colour shift inks, that are difficult to replicate at low cost.

Covert measures are in the main invisible to casual viewers and are a key method of identification of counterfeit product. Techniques employed include UV varnishes with known subtle changes to their repeating patterns, micro-text (very small text, invisible to the naked eye and only reproducible by specialist printing), reactive inks and chemical tagging agents, all allowing the legitimacy of a pack to be validated by the dispenser or investigating authority. Implementation costs for all these methods vary, as do their success rates, but each endeavour to make the counterfeiter’s task a little harder.

These approaches have been employed individually by companies, each organisation seeking to find a solution that protected their products and their patients, largely in isolation. In 2006 however a World Health Organisation coalition of stakeholders called IMPACT (International Medical Products Anti-Counterfeiting Taskforce) was established, seeking to make a step change in anti-counterfeiting measures and drug security. This coalition sought to identify standards and initiatives that could be implemented across borders to address the pernicious rise in counterfeiting globally. For the first time, realistic, holistic approaches could be envisaged, exploiting innovative technological solutions that could make the tracking and tracing of product possible from manufacture through to dispensing.

To give some context to the potential size of the problem, US figures suggested that if 1% of the 3.4 billion prescriptions issued in the US in 2006 were dispensed with counterfeit product, then 34 million prescriptions could be affected. In other countries the problem is thought to be much higher, affecting perhaps 30% of all prescriptions.

The state of California attempted to take the legislative lead back in 2004, with portions of their anti-counterfeiting and anti-diversion legislation requiring implementation in 2005/06. The electronic pedigree elements first came into effect in 2009, requiring full traceability of product from manufacture to pharmacy, at ‘immediate container’ level, though the implementation deadline has now been pushed back to 2015. Serialisation of the saleable unit remains the primary requirement, requiring electronic systems to track, trace and document all transactions.

inpharm datamatrix

Elsewhere, India has recently announced mandatory serialisation requirements for all exported products from July 2011, through the use of 1D and 2D barcode implementation on primary, secondary and tertiary packaging. The European Parliament, following a successful trial in Sweden, have recently (Feb 16 2011) progressed a directive that will require all companies manufacturing and handling medicines within the EU to address anti-counterfeiting in their distribution chains. Amongst the measures (which include the compulsory use of tamper evident labels) will be the adoption of mandatory, pan-European pack serialisation, most likely through the use of 2D barcodes, allowing pharmacists to instantly know if a pack has been dispensed with the same serialisation code. This builds on the recent implementation in France of Data matrix codes containing product identification number, batch number and expiry date information on each pack. Following final approval by the Council of Europe, national governments will then implement serialisation legislation locally, with a possible European-wide deadline for completion.

So, the clock is counting down towards a major milestone in anti-counterfeiting. Technology partners have the solutions to manage these new and complex data requirements. Systems are available to allocate, print, check and manage serialisation data and share it across the supply chain and pharmacist network, both at national and international levels, integrating with existing manufacturing, shipping and receiving transactional systems. As a by-product this has the potential to deliver greater visibility to supply chains of real-time sales data, making for more effective demand management – companies can manufacture product against real sales as opposed to forecasts and thereby realise efficiency benefits.

What is undeniable is the significant increase in costs for the whole pharmaceutical sector, in manufacturing, warehousing and dispensing, that will be required to meet the directives. Good consultancy advice will therefore be paramount in implementing the most appropriate and cost effective solutions for pharmaceutical businesses.  

Pinnaculum and other specialist industry consultants stand ready to assist companies, delivering both patient safety and improved revenue by reducing counterfeiting opportunities to an absolute minimum. The arms race of counterfeiters versus legislators, pharma companies and solution providers will continue long into the future but new technologies and initiatives can give reason for optimism.

Mark Wilkinson is managing director of Pinnaculum, a specialist graphics and packaging management consultancy to the pharmaceutical and life sciences sectors, who support their clients through outsourcing, technology, consultancy and creative services. www.pinnaculum.co.uk

This article appeared in the April 2011 edition of Pharmafocus

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Joining up the dots. Braille implementation in the pharmaceutical industry

For a few years now, medicines legislators have sought to address the needs of the partially sighted in aiding the identification of pharmaceutical products and the communication of their contents, warnings and contra-indications. Having completed an exercise myself under blindfolded conditions it is easy to understand the  importance of the issue and the difficulties experienced by visually impaired patients – the risks of taking the wrong medicine or of not being aware of contra-indications are significant. A European Union Directive 2004/27/EC, encompassed three core requirements;

  • The availability of Patient Information Leaflets in audio form
  • The provision of Braille Patient Information Leaflets
  • Braille on outer packaging

Service providers have been established to provide PILs in audio and Braille form and Pinnaculum can manage the supply of these items for their clients. However it is in the implementation of Braille characters onto artwork and printed packaging components that we can significantly assist our clients.

Recent initiatives at National levels have sought to standardise what was a plethora of national requirements into a standard specification for Braille.  More specifically, a French labelling decree (Decree 2008-435, Article R5121-138,  6 May 2008) set the implementation pace in Europe alongside Germany and Austria, requiring that all French products (with the exception of hospital only products) should include Braille on the outer packaging with an implementation deadline of May 2009. The French market had an additional requirement, namely the use of Antoine Braille, a variant with specific ways of describing numbers.

More recently the MHRA in the UK set a deadline of October 2010 for the implementation of Braille on outer packaging marketed in the UK, again with the exception of hospital only products. Across European markets, exactly what wording should appear on the packaging in Braille varies, making knowledge of individual country requirements paramount.


The creation of artwork with Braille requires early communication with manufacturing sites and their printed component suppliers. The Braille itself is typically produced by embossing where a male Braille plate is created to the individual pack’s requirements that is ‘pushed’ into a standard female Braille plate set into the carton’s cutter guide form. Correct artwork in terms of Braille size and positioning is therefore critical in ensuring Braille characters are correct and in the right place. Braille plates are expensive so good checking procedures can prevent unforeseen costs and time delays from occurring.

Other implementation technologies are available, including Braille ‘stickers’ that create a Braille patch out of resin or another light substrate that is then stuck onto the component. The embossing of cartons though is the most typical implementation route.

Once the original artwork has been created and reviewed and having printed the carton component with the Braille characters, the final step in the quality control process is to verify that the Braille is correct. This can be achieved most effectively using Braille verification technology.

Pinnaculum have been ensuring the correct implementation of Braille in all its forms on components for a number of years. Our artwork studio is proficient in all its vagaries and our technological knowledge can assist and advise both component printers and quality functions in manufacturing sites as to the most effective solutions for ensuring the compliant implementation of Braille on a wide variety of components. If you are struggling to implement Braille on your product packaging or need an experienced voice to talk to, give us a call or post a question/comment below. We’d be only too happy to help.

Mark Wilkinson

Pinnaculum is a an end to end artwork management service provider, incorporating technology, outsourcing, consulting and creative services. We are devoted to delivering effective solutions and compliance in the pharmaceutical and life science sectors in the areas of artwork creation, design, control, and implementation. Our services address the needs of Supply Chain/QA/Regulatory Affairs and Commercial Sales and Marketing departments.

Failure to implement changes or demonstrate effective artwork control remains a major cause of product recalls and reworks for packaging and/or errors and complaints on the commercial sales and marketing side. Good artwork management practice and control & implementation systems mitigate against such outcomes. With knowledge in this field not always naturally available in many pharmaceutical and life science companies, Pinnaculum provide a range of process driven and creative services to assist clients in this specialist area.

Posted by Mark Wilkinson

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Packaging error driven product recalls in the pharma industry

Product Recalls
packaging errors remain the largest cause of product recallsIt is well known that product packaging errors remain a significant cause of product recalls through non compliant implementation or labelling errors. Poor labelling design also contributes to a large number of prescribing errors by pharmacists. Both these problems can have a detrimental effect on your company’s reputation, your bottom line and indeed the patient.

Meeting the challenge
Addressing these issues along with the full gamut of associated requirements and challenges in the most efficient and compliant manner is paramount to most companies. Unfortunately, packaging design and artwork management are not natural skill sets found in the pharmaceutical & life sciences industries, which is the reason why more and more companies turn to industry experts for the design and artwork management of their product packaging.

Experience
Understanding and meeting the pack management needs of the pharmaceutical sector and reducing labelling driven product recalls has always been Pinnaculum’s mission. Pinnaculum are specialists in this area with over 20 years experience in assisting global top five through to small pharmaceutical companies in creating and managing their printed packaging components.

Best in class solutions
We seek best in class solutions in terms of economy, speed and quality. Our disciplined approach and expertise helps bring new products to market quicker and labelling change implementation compliance. Our quality driven processes and methodologies prevent labelling driven product recalls and the impact they can bring to pharmaceutical companies and their reputation.

CALL US TODAY +44 (0)1438 791113We can help
Whether you are looking for assistance in improving your own internal systems or are looking for a full third-party service, talk to us today to see how Pinnaculum could become your partner of choice and deliver financial and quality benefits, giving you peace of mind in this specialist area whilst allowing you to focus on your core business.

Posted by Mark Wilkinson

Filed in product recalls, labelling design, packaging errors,

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