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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Summer 2006
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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Industry Insight 
In her Editor's Letter, Patricia Lobo takes a look at the topics in this issue  
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Manufacturing
Substances that bear the risk of breaching elastomeric closures must be evaluated by subjecting the packaging to more severe stress conditions than normal, says Stelmi's Laurent Caburet, in Extractables: Injectables and Elastomeric Closures  
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In Manufacturing a New Approach by Jim Tizzard and Mike Giffin at WCI, a solution is presented for manufacturers looking to improve compliance and performance  
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Drug Delivery 
Dose counters on pMDI devices are an effective route to increased patient compliance - John Olley at Bespak sets out the facts and examines the implications for business in Comply and Control  
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It is not just the pharmaceutical sector that profits from research into powder technology; manufacturers that use ceramic or metal components will also benefit. In Powder Power, Dr David Whittaker at PowdermatriX presses for greater collaboration between industries  
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Labelling 
A result of increasingly downward price pressures, the shift in the manufacturing sector from development and delivery to commercial efficacy is traced by Cenexi's Philippe Mougin, in Outsource Your Troubles  
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Dr Kevin Ward at Biopharma Technology proposes a more rational and analytical approach to freeze drying, in Lyophilisation: Art or Science?  
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Packaging, Packing & Anti-Counterfeiting
US requirements for child-resistant packaging are more stringent than in Europe. In From Cradle to Grave, Tom Grinnan at Meadwestvaco evaluates a worrying safety gap caused by obstacles in the bureaucratic process  
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Almost every industry is affected by piracy. In The Colour of Your Money, Nicole Golomb at Simons Druck investigates colour-code particles that protect pharmaceutical products by providing a unique traceable identity  
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With counterfeit medicines making up an estimated 8 to 10 per cent of the world's drug supply, Eddie Dodds of BT Auto-ID Services looks at the value of mass serialisation, in Track, Trace, Authenticate  
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In Talking Medicine, Peter Harrop at IDTechEx explores smart packaging, tamper recording, anti-counterfeiting and the other potential benefits of RFID for pharmaceutical packaging  
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Formulations, Ingredients and Excipients
In Making the Grade, Oliver Luhn at Suedzucker AG and Bodo Fritzsching at Palatinit reveal a new and more effective way to deal with variable compression rates in tablet formulation  
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Andrea Zaccagnini at Ark Organics expounds the benefits of outsourcing custom synthesis to specialised partners who can perform the synthetic tasks needed for their projects, in Developing Partnerships  
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Pharmapack 2010 supplement
In A Roadmap to 21 CFR Part 11 Compliance, Dr Wolfgang Brysch of BioMedion plots a route to cost-effective implementation of this complex FDA regulation  
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In light of recent changes to legislation for the carriage of dangerous goods by road, Pieter G Wildschut at DGM asks what is now required when transporting hazardous materials, in The Travelling Bug  
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IT and Logistics
People don't die from carrying a fake handbag or wearing a fake T-shirt, but they can die from taking a counterfeit medicine. Julian Mount at Pfizer delivers a timely warning, in Supply Chain Reaction 102 Freight Matters - PMPS talks to Andrew Hughes at Pharmafreight about pharmaceuticals, logistics and good transport practice  
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Eric Raemdonck at the International Air Transport Association discusses the factors that influence the properties of perishable goods in transit. Keep Cool or Perish points out the hotspots  
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In Thermal Mapping - Before and After, Acutemp's Clint Parks outlines an important component of temperature-sensitive packaging design, that offers pharmaceutical manufacturers assurance that their product will be reliably delivered  
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In VIPs Only, Win Eastman at Kern Frio details new trends and technologies for the distribution of medical products at controlled temperatures and highlights the financial advantages of more efficient insulation materials  
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In conversation with Wassermann's Karsten Schaaf, PMPS uncovers the intricacies of supply chain management, in Chain of Command  
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Validation & Compliance
In Better in Retrospect, David Forrest and Carl Turner at Compliance Control chart a brief history of manufacturing compliance and measure the vast mountain of retrospective validation that companies must climb  
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With regulatory authorities growing increasingly enamoured with risk-based approaches to validation, Mikael Fenger at NNIT tackles the challenges posed and the potential merits, in Risk and Reward. Does your risk management method define responsibilities with enough clarity?  
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Previews
Following last year's success in Madrid and with October's P-MEC show on the horizon, why not Be Part of the Complete Manufacturing Solution? Come to Paris from 3rd-5th October to sample the best in manufacturing  
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PharmaIQ profiles the key speakers and main events at Pharma Secure Chain 2006, taking place in London this November  
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Published quarterly in
February, May,
August, and November

News and Press Releases

Leading pharma packaging companies commit to supply for Covid-19 fight

The CEOs of Gerresheimer, Stevanato Group, and SCHOTT are committed to ensuring ample supply of pharmaceutical containers for any Covid-19 vaccine and treatment that is developed, and that no patient shall be left behind, no matter what region of the world they live in. Also, the companies will make every effort to support the pharma industry’s’ priorities for overall medication supply in addition to Covid-19 drugs. Each of the three companies manufactures billions of type-1 borosilicate glass vials, the most proven and most widely available material used to store and deliver vaccines around the world. They are making the statement to provide confidence in the global pharmaceutical supply chain in times of uncertainty.
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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

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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