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Pharmaceutical Manufacturing and Packing Sourcer

A Common Language

The global landscape for clinical trials continues to expand. As pharmaceutical companies look beyond traditional developed markets for future growth, R&D has become a truly international activity; drug companies are not only establishing an operational presence in countries across the world, they are also partnering with clinical research and manufacturing organisations in local markets to expedite drug development and accelerate product to market.

At present, clinicaltrials.gov estimates that registered clinical trials activity is being carried out in more than 148,000 locations across 185 countries. While the majority of these trials are being conducted in established, traditional markets – with the US alone accounting for 41 per cent of all trial activity – a growing number of studies are taking place in developing nations due to the availability of suitable patients and the lower costs of performing trials.

There is particular focus on the emerging ‘BRIC’ nations – Brazil, Russia, India and China. With accessibility, data quality, healthcare, internet and IT infrastructure in these countries improving, pharma companies are recognising them as important locations for clinical research.

As the evolution continues – and as emerging economies become more attractive propositions for Big Pharma – the battle to ensure that supply chain management across multiple countries is secure, efficient and effective will become ever-more challenging. And nowhere are these complexities greater than in the important global arena of clinical trial labelling.

Appropriate Labelling

Ensuring pharmaceutical products are correctly and clearly labelled, particularly in terms of local language labelling, is imperative to safeguard patient safety and meet legislative requirements. It is vital to make sure that users are provided with the right information about the product they have been sent and how it needs to be stored and administered.

The best way of achieving this is to ensure that labelling speaks to users in the most appropriate and understandable language. This may be a simple enough objective, but meeting it is far more complex. To proceed, it is important to define the scope of labelling, understand current market dynamics and set a roadmap to deliver best practice.

‘Labelling’ is actually a broad church, with the term encompassing the following different items:

Labels

Generally, these are single-panel labels; adhesive-backed paper or synthetic labels onto which specific data is printed. Labels can be single language, but when there is enough room, multiple languages can be printed. Countries where the same language is spoken, but certain information – such as the sponsor – changes, can also benefit from a single-panel approach. Single-panel labels are usually printed on demand or in a batch process.

Booklets

Booklets are multi-page to communicate information in multiple languages and, as such, are complex to design, populate with data and create. They generally comprise an adhesive back page; a front cover that is able to be printed with patient-specific and product or batch data at the time of dispatch; a spine; and an index to identify country-specific pages. In order to make the production of booklets more efficient, customised ‘overprinting’ brings together the advantages of bulk production of the booklet content with the just-in-time requirement of the label printing.

Instructions for Use

This is the information leaflet within a pack or container that provides user guidance for the patient. Such leaflets are less common in clinical trials due to the use of booklets, but they may similarly be required to include product-specific information in multiple languages.

The complexities of labelling also extend to the many fundamental elements that apply to label design – irrespective of whether they are single-panel, booklets or instructions for use. These comprise text, country-specific phrases, variable production data, barcodes, icons, logos and pictures. As local legislatures retain control of clinical trial regulations, these requirements will vary from job to job, from country to country or even region to region.

Multi-Language Dynamics

With clinical trials now a global business, the need for appropriately translated instructions is paramount to ensure supply chain efficiencies and maintain patient safety. But with most languages subject to localised nuances, achieving accurate translations remains a key issue. Furthermore, at present, data can come from a range of systems: trial data, randomisation data and production data – making a difficult process even more complex. As such, robust management is required to bring version-controlled information from all systems together to print at the point of dispatch.

In addition, each trial location is likely to be governed by country-specific regulations – meaning label design will differ depending upon the destination country. While this can be relatively straightforward when printing single-panel labels, or taking an on demand approach, it is much more challenging for booklet design, where large amounts of information need to be managed in multi-page and multi-language formats. Once a stock of booklets has been bulk printed, there is little chance to make further changes to the booklet itself due to the massive cost of production. The only option is a mass reprint, which will incur significant costs in terms of both time and money.

Common Challenges

Currently, companies are struggling to find a reliable way of approving and locking down local language data – heightening the risk of products being incorrectly labelled. There is huge variability in how organisations across the sector are managing this key process: some have developed in-house processes that rely on a number of disparate systems that are not joined up; others rely on labour-intensive manual processes, at great expense.

This multiplicity of approaches has led to a series of common challenges across the industry. Companies need to:

  • Know which countries a trial might be run in – as early as possible
  • Ensure all phrases are translated and approved in good time
  • Make sure local language nuances are addressed
  • Address all local regulatory requirements
  • Ensure data is managed from one place and can populate all assets
  • Make sure data is managed and maintained independent of asset design
  • Ensure the right data is available at the right time
  • Establish how a drug will be packaged
  • Understand which labels will be used
  • Ensure that the label design can accommodate all the required information
  • Make sure that processes and systems are in place to approve data, text and design
  • Decide whether labels will be produced in-house or outsourced
  • Identify the right partners

Roadmap to Uniformity

Despite these common challenges, the lack of a uniform approach to clinical trial labelling is building avoidable inefficiencies into the supply chain – leading to an increase in unnecessary and duplicated quality checks, the deceleration of product to market and an escalation in development costs.

A continuation of this approach is no longer sustainable. The industry must develop a consolidated approach to clinical trial labels, booklets and packaging. Companies must work collaboratively to bring disparate processes together in a single, secure, version-controlled and auditable process to manage every stage of label lifecycle management – from the physical translation and storage of phrases, design of labels, to the final printing and verification. In particular, the introduction of a single-solution strategy can help organisations reap the benefits of reducing errors, removing duplicate quality checks and eliminating the costly and avoidable return of materials.

The development of a consolidated approach will depend upon integrating a number of base capabilities that are common throughout any fully compliant system that meets current Good Manufacturing Practice standards, as well as country-specific requirements. At present, these capabilities are generally delivered independently via isolated systems – an approach that is prone to causing confusion and can also increase operational overheads and risk. The single, standard end-to-end solution must therefore provide a common and reusable approach to security, version and revision control, audit and configurable reporting.

Security and Audit Trail

All stakeholders in the clinical trial labelling process expect a highly secure audit trail to be maintained. This must allow aspects such as robust historical transaction logging, the ability to record format design, source phrase, trial phrase and all variable data, and searchable, exportable information.

Configurable Reporting

Reporting capabilities must allow transparent access to all aspects of audit logging: what has been done, when, transaction type, user, machine and data. It should also enable access to and reporting on the data held within the system: product data, translations and trial information.

Version and Revision Control

This should be common throughout the system – and will need to provide a standard and reusable process. Assets such as dictionaries and phrases, template designs and data all need to be version controlled. Likewise, the approach to approvals is equally important and can be either single item or job-based approvals. The underlying principles remain the same. A job-based approach can be adopted where there is the need to approve multiple assets. The ability to add additional supporting information, such as documents, and to provide approval or rejection comments during the process can be very useful.

In more advanced systems, proactively managed approvals are starting to be seen, whereby emails are sent to required approvers, as well as the more sophisticated management of rejected approvals. These are helping companies to reduce duplicate processes in quality control by increasing appropriate accessibility to stakeholders via user-specific security levels throughout the process.

Greater Efficiencies

As the industry seeks to exploit opportunities in emerging markets such as the BRIC nations, while also improving performance in traditional, established markets, there is little doubt that the packaging and labelling process could be more efficient. Historically, companies have managed the design, data management and print process as three distinct and separate areas – in the process, building in multiple manual visual checks to ensure quality control. However, to progress, and to conquer some industry-wide challenges, companies need to work together to build a more integrated system for clinical trial labelling.

The optimal solution will be able to manage users through every step of data creation, design, management and printing, and will most likely be underpinned by robust and reliable end-to-end automated processes including vision inspection. Holistic systems that can capture and manage label data right across a trial, and bring it all together at the right time, can transform the industry’s approach to trial labelling, reduce the inefficiency and cost of drug discovery and accelerate a product to market.

Furthermore, integrated web-based solutions that offer deployment benefits and easy access for in-house users and third parties will not only provide a strong platform for the natural introduction of just-in-time printing, but will also reduce the need for, and associated cost of, printing multi-language booklets in bulk.

The tools for integration and the building bricks for future success are out there. To optimise them in a competitive multi-language, multi-country marketplace, the industry must be prepared to collaborate and innovate. The problems are common – and we should all be speaking the same language.


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Vince Postill is Senior Vice President of Global Business Development at PRISYM ID. He is tasked with building strategic relationships with key partners to increase market share by building compelling joint value propositions with the company’s software, as well as establishing joint venture relationships with other companies. Before joining PRISYM ID in 2004, Vince worked for a number of Auto-ID companies and was responsible for product management and the subsequent sales of defence electronics, environmental monitoring equipment, specialist printing software and interfacing technologies.
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