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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Winter 2009
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. PMPS provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in this issue of PMPS.
   
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Manufacturing
As outsourcing of manufacturing processes becomes an increasingly attractive option, the quality of quality assurance must be tackled. Andy McCallum at Tepnel Research Products & Services provides an in-depth discussion of how best to carry out an audit of an outsourcing provider.  
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The implementation of lean management priniciples often sees businesses having to make a direct choice between efficiency and responsiveness. Andreas Bahne at Boehringer Ingelheim investigates how the implementation of business process excellence alongside lean manufacturing can overcome this problem.

 
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The NHS has never been under more pressure to modernise and reduce costs. Peter Williams of MTS Medication Technologies Ltd argues that, in order for this to happen, the role of the pharmacist needs to evolve, and greater integration is fundamental.

 
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There is no doubt that the recession has hit some companies harder than others and, on the surface, it seems difficult to identity why this is. Steve Hemsley at Lanner suggests that companies are better equipped to face up to trying circumstances if they have accurate, up-to-date information at their fingertips.  
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Drug Delivery 
John A Vennari at West Analytical Services investigates how the application of quality by design principles, especially when working in tandem with analytical laboratories, can streamline the drug development process.  
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Steve Craddock at Doyen Medipharm Ltd looks at the latest technologies involved in the development of transdermal device manufacture, and suggests that mass production and device quality needn't be mutually exclusive in the manufacture of transdermal patches.  
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The application of computational fluid dynamics in the pharmaceutical industry has had mixed reviews; James Tibbatts of Concept Flow argues its case, identifying instances in which CFD offers unique benefits to those who utilise it.  
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The production of insulin for oral administration has long been seen as an elusive goal for drug manufacturers. Woei Ping Cheng at the University of Hertfordshire and Colin Thompson and Rachel Knott at Robert Gordon University investigate why this is the case, and consider potential future developments.  
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Formulations, Ingredients and Excipients
The use of reference standards in chemical analysis originates outside the pharmaceutical industry, but it has found its way into formulation procedures. Christian Zeine at LGC Standards outlines some common pitfalls to which pharmaceutical companies should be alert.  
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The most fundamental demand on drugs formulated for oral delivery is that they are easily absorbed from the gastrointestinal tract. This can often pose significant challenges for formulation scientists. Robert Harris at Penn Pharma discusses how these challenges can be overcome.  
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IT and Logistics
One option for thsoe seeking to streamline track-and-trace processes is the use of holograms. Ian Lancaster of the International Hologram Manufacturers Association discusses the benefits, and outlines their potential for future development.  
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Emily Sopensky at the RFID Educational Foundation, Inc claims that an asset that can help companies ride out the financial storm is a comprehensive knowledge of the technologies available to them, and that this can be ensured by a focus on education.  
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PACKING, PACKAGING & ANTI-COUNTERFEITING
Counterfeiters are constantly finding ways to infiltrate an increasingly complex supply chain. Marcus Lawson at First Ondemand argues that the war against counterfeiters must go beyond simply relying on technological innovation, and that efficient management and coordination is a must.  
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The practice of parallel distribution has consistently provided a platform for lively debate between players in the pharmaceutical supply chain. Heinz Kobelt of the EAEPC argues in favour of parallel trade, suggesting that, when implemented correctly, it can ultimately protect patient safety.  
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Another sector which is having to face up to new EU regulations is labelling. From October 2010, all medicines that are distributed through retailers in the EU Member States will be obliged to bear Braille markings. Kurt Kjellerup at CCL Label explains that the new challenges can be met with the latest digital production methods.  
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Bernd Webel of Romaco Pharmatechnik GmbH provides an update on the technological developments in the field of blister packaging. He discusses how innovation has driven the development of machinery that guarantees product quality and safety.  
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COOL CHAIN
The increasing globalisation of pharmaceutical supply networks demands improved efficiency in temprature-sensitive shipping - a requirement that is not always being met. Keith Ulrich at Deutsche World Post Net outlines the failings in the current systems and examines the actions being taken to rectify them.  
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The latest EU environmental protection legislation has seen the prohibition of the use of R22 refrigerant. As the phase-out looms, John Davey at Harp International tells us what businesses can do to prepare themselves and maintain efficiency in their operations.  
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

Published quarterly in
February, May,
August, and November

News and Press Releases

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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Industry Events

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
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