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Pharmaceutical Manufacturing and Packing Sourcer

Track Your Progress

While serialisation in the pharmaceutical supply chain is generally regarded as inevitable – counterfeiting is simply too large of a problem to not be addressed – some uncertainty around the specifics exists, particularly from a global position. Regulations are advancing at various speeds around the world, and, to date, global standards as to how serial numbers should be formatted have not emerged.

Progressing Through Uncertainty

This has demanded that manufacturers move forward cautiously in their approach to serialisation. They must take steps to prepare without committing themselves to technologies that may not support future requirements. To that end, many have placed systems necessary to apply and capture serialisation data in their packaging processes, but have, in general, not addressed the impact of tracking these numbers across the supply chain.

This is partly due to the nature of a typical pharma supply chain, which is more dependent on third-party logistics providers for downstream processes than other industries. These providers enable companies to minimise supply chain assets and focus their capital on R&D, but they tend to limit their investments in automation because short-term contracts do not allow a return on investment within the contract period.

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Michiel Veenman, Global Market Leader at Swisslog Warehouse and Distribution Solutions, has worked with various pharma companies to design advanced intralogistics solutions prior to taking on his current role. As such, he is responsible for continuously improving the company’s contribution to the market. This includes market research, organisational development and training and solution design, as well as systems support. Having studied logistics, Michiel has experience working for the Dutch Department of Defense and in automation system simulation and analysis. Before joining Swisslog, he spent five years optimising warehouse operations and IT systems for a small veterinarian pharma wholesaler.
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Michiel Veenman
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News and Press Releases

Synpromics announces a research collaboration with GE Healthcare to extend the toolbox for production of biologics

Edinburgh, UK, 4th January 2017 – Synpromics Ltd, the leading synthetic promoter and gene control company, is pleased to announce a research collaboration with GE Healthcare to jointly develop customised synthetic promoters optimised for GE Healthcare’s proprietary biopharmaceutical manufacturing platform.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

12th annual Cold Chain Distribution Conference and Exhibition

13-14 December 2017, Copthorne Tara Hotel, London, UK

Responding to the evolution within the industry, SMi is proud to announce the return of its leading 12th annual Cold Chain Distribution event. Returning to London in December, this year's event will remain at the forefront of innovation
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