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Pharmaceutical Manufacturing and Packing Sourcer |
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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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| With non-GMP regulations leading to an overlap between the roles of the Qualified Persons in pharmacovigilance and manufacturing,Marty Boom of WCI explains how any tensions should be avoided, as both ultimately have the same goals. |
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| Sean L Kitson at Almac shows how synthetic organic chemistry, key technologies (such as radiolabelling) and cGMP must be combined in the drug manufacturing process to achieve the highest standards possible. |
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| Mark Botting at Isotron highlights the importance of a variety of techniques which allow the contract steriliser and manufacturer to achieve the required regulatory targets. |
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| Process analytical technology provides manufacturers with an essential tool in dealing with the crucial market drivers that shape a pharma company’s strategy, explains Dean Chespy at Siemens Industry Automation. |
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| Rodolfo Valdés and his team from the Center for Genetic Engineering and Biotechnology, Havana, Cuba focus on immunoaffinity chromatography in vaccine manufacturing, and provide a detailed example of its application. |
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| Chuck Reed at Weiler Engineering analyses how modern aseptic blow-fill-seal technology can improve the speed and quality of liquid manufacture, while also offering stronger protection against contamination. |
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| Polymeric flooring is a far more effective solution to cleanroom particulate contamination than other technologies such as peel-off mats, writes Gerry Prout at Dycem. |
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Real-time tracking technologies and their perceived effectiveness in business are examined by David Bang of LifeConEx, who points out the apparent lack of actual examples. |
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New and thorough air cargo screening regulations are coming into force in the near future, and will put pharma transport contractors to the test – especially those that are unprepared, explains independent writer Robert Moorman. |
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| Rania Salama of the University of Sydney, Australia shows how several characteristics of the human lung make it a highly effective location for the administration of treatments for pulmonary disease, although there are plenty of challenges facing the controlled release manufacturer. |
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| Transdermal deliveries offer an empirically proven solution to controlled release for a wide range of conditions, according to Robert Falcone of the New Jersey Institute of Technology and Bozena Michniak-Kohn of the State University of New Jersey, who go on to highlight current approaches and technologies. |
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| Maxime Laugier at MP5/CREAPHARM discusses strategies to avoid crosscontamination in the manufacture of drug delivery systems, and assesses the differences between single and multi-use equipment. |
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| Counterfeit drugs present a real and tangible threat to manufacturers and distributors alike, says Vince Postill of PRISYM ID, who outlines the measures available to halt their spread. |
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| Frederic Menardo of Systech International and Graham Smith of Aegate argue that serialisation technology must be more widely taken up by the pharma industry, particularly in the face of impending anti-counterfeiting legislation. |
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| As well as providing effective weapons against product piracy, serialisation and track and trace technologies can also add value to genuine products, points out Steve Wood at COVECTRA. |
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| Non-adherence is a major problem in the healthcare industry;Ted Lithgow at MWV explains that innovation is required to reduce the scale of the issue, with adherenceenhancing packaging presenting an effective and cost-reducing solution. |
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| Jorge Sassone of Improvement-Proquimo provides a detailed analysis of formulation in the lyophilisation process, outlining the essentials of each stage and their importance. |
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| Lyn Hughes of Dow Water and Process Solutions argues that taste-masking improves adherence and can give a manufacturer a competitive advantage. |
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News and Press Releases |
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PCI and CSP Technologies, Inc. Announce Strategic Collaboration for Breakthrough Activ-BlisterTM Solutions
Philadelphia, PA & Auburn, AL – September 17, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce its exclusive collaboration agreement with CSP Technologies, Inc. for U.S. clinical trials and stability testing utilizing Activ-BlisterTM packaging solutions, which help protect and promote speed-to-market for pharmaceutical and medical device products with heightened susceptibility to moisture and gases, especially oxygen.
More info >> |
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White Papers |
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PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content
Phlexglobal Ltd
Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive.
As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
More info >> |
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Industry Events |
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SCOPE Europe: Summit for Clinical Ops Executives
16-17 October 2018, 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 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.
More info >> |
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