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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Spring 2011

   
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Manufacturing
As the economic tide starts to turn and the industry regains a more positive outlook, Philip Pratten at Elan Drug Technologies describes five central trends that contract manufacturing will undergo in the near future.
 
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Dave Smith at Catalent Pharma Solutions shows how the concept of Lean can offer manufacturers a healthier, more efficient approach that seeks to cut back on waste and support a sustainable working environment, while remaining profitable.
 
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Cool Chain, Cargo & Logistics

Jim Hardisty at Goplasticpallets.com looks at the advantages of plastic pallet technology over the traditional wooden variety, and cites examples to support the adoption of this more sterile, safer option.

 
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Tristram Evans at Biotec Services International Ltd considers the trickier aspects of importing investigational medical products into the EU, including the regulatory hurdles and Qualified Person certification processes that must be followed to guarantee swift progress.
 
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When transporting drug products to clinical trial sites, it is essential to be fully aware of their status and location. Alex Klim of DHL Supply Chain outlines the importance of robust IT and data management solutions as a means to ensure products transit safely.
 
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Brandon Fried of the Airforwarders Association introduces the measures that have been put in place for the screening of all pharmaceutical cargo coming in and out of the US.
 
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Drug Delivery 
The role of the end-user should never be underestimated when designing and marketing a drug delivery device. Iain Simpson and Kay Sinclair at Sagentia introduce the new human factors standards that have come into force and advise on how manufacturers should adhere to them.
 
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Patient compliance can be achieved more easily than one might expect, thanks to the advanced systems currently available. Norman Niven at Protomed dispels some of the myths surrounding this technology.
 
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Multi-particulate dosage forms, such as fluid-bed pelletisation, present drug manufacturers with an adaptable avenue for the production of therapies requiring controlled release dosage, as Norbert Pöllinger at Glatt Pharmaceutical Services explains.
 
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Tom Martin at 3M Drug Delivery Systems considers how companies can best adapt their manufacturing capabilities to take advantage of microneedle technology for transdermal delivery – a platform that is gaining importance in the controlled release sector.
 
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Packaging, Packing & Anti-Counterfeiting
Tightness and impenetrability to the external environment are hallmarks of a strong packaging solution. Glenn Svedberg at Nolato Cerbo AB picks out the features that should be at the forefront of any manufacturer’s mind when seeking to strengthen their seals.
 
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Phil Stevenson at Sepha looks at the benefits of laser testing devices for analysis of blister pack integrity, and argues that the technology offers a more accurate and secure alternative to the standard blue dye tests that are already in use.
 
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David Edwards at Capsugel and James Johnston at Aptuit showcase the Xcelodose® precision powder micro-dosing systems for the production of capsules for use in dry powder inhalers.
 
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Andrew W Goll at Weiler Engineering, Inc points out the value of advanced aseptic blow-fill-seal technology for the filling and packaging of pharmaceutical liquids, and highlights some of the key features of the process.


 
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Mathias Kreher at Bosch Packaging Technology puts forward barrier isolation technology as the key to guaranteeing an aseptic filling line and sterile conditions.
 
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Huw Kidwell at Dolffin looks at improving tamper-evidence to ensure that no one can affect the perfect condition that the end-user expects product containers to arrive in.
 
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Michael Nieuwesteeg at NVC Netherlands Packaging Centre presents his organisation’s ΦΠΙ project, which aims to improve user-access and compliance for all types of pharmaceutical packaging,with the world’s changing demographics and ageing population in mind.
 
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The European Parliament recently voted to amend the existing 2001/83/EC Falsified Medicines Directive concerning the security of pharmaceutical products.Pascal Durdu at Zetes assesses the impact of this new development.
 
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Rick Raber at Northern Apex examines the role minimally invasive item level serialisation can have in achieving a manufacturing flow which incorporates RFID and security without a dip in speed or efficiency.
 
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RFID labelling is generally hailed as the future of pharmaceutical product security, but does it live up to its reputation? Mark Beauchamp at Citizen Systems Europe offers barcoding as an older but potentially stronger solution.
 
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the end of the line
Richard Harrop explains why nostalgia does have its place when it comes to good product design.
 
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

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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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