spacer
home > ict > autumn 2016 > a question of standards
PUBLICATIONS
International Clinical Trials

A Question of Standards

In 2013, the International Society for Pharmaceutical Engineering (ISPE) launched a survey to analyse the relationship between patient compliance and packaging (1), in which subjects of clinical trials were asked about their experience when applying investigational medicinal products (IMPs). An overwhelming 77% found their medication easy to use. Since the questionnaire was almost exclusively based on responses by patients from the US, it was expanded in 2015 to include the UK, the EU and Asia. The favourable opinion was, again, confirmed: the majority of participants gave positive feedback regarding the overall ease of application of their IMPs – both in the EU (85%) and in China (88%).

The more user-friendly the labelling of IMPs is, the simpler they are to use. This equation takes centre stage considering the growing demand from subjects for medication to be delivered straight to their homes (75% in the EU; 78% in China; 78% in the US in 2013). In contrast to briefing on the phone – which always means extra work for site personnel – dosing instructions on the package are directly and durably attached to the drug. To be accessible, additional digital information usually requires analogue placeholders on the packaging – such as QR codes – which can only be read by means of technical devices. Having functioning hardware and software is, therefore, a prerequisite.

Just-In-Time Labelling


The labelling of IMPs is subject to demands that are specified in the Good Manufacturing Practice (GMP) Guide within the EU (2), and in the Code of Federal Regulations (CFR) in the US (3). They mostly apply to blister packs or bottles as far as the primary packaging of clinical IMPs is concerned, and to labels on secondary packaging. Label content is governed by EU stipulations in Annex 13 to the Guide, with layout, font size and symbols laid down in the Guideline on Readability (4).

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Nurdan Citamak joined Faubel Pharma Services in 2013 and was appointed Director of Business Development and Sales for North America. She graduated in Business Administration from Würzburg-Schweinfurt University, Germany, and majored in International Business at Bond University, Australia. Prior to joining the company, Nurdan spent nearly seven years in New York working in the technology industry.
spacer
Nurdan Citamak
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

CPI to showcase results from BioStreamline project developing novel biotherapeutics

CPI, a UK-based technology innovation centre and a founding member of the High Value Manufacturing Catapult, announced today that it will host an event in Darlington, UK on 26 June 2019 to disseminate the results of the £11.2M BioStreamline project to optimise the development of novel therapeutics. During the event, the project partners — Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI — will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
More info >>

White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
More info >>

 
Industry Events

SCOPE Europe – Summit for Clinical Ops Executives Europe

17-18 September 2019, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical innovation leaders, clin ops execs, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World. The event will feature opening and closing plenary keynote sessions, five conference tracks, interactive breakout discussion groups, and networking. It is an opportunity for leaders from large, mid-sized, and small pharma, specialty pharma, biotech, vendor companies, and academic research centers to come together to share best practices and discuss the new era of analytics-driven and patient-centric trials.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement