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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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| In her Editor's Letter, Dr Patricia Lobo provides a brief summary of the articles in this issue of PMPS |
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| In Providing Global Access to Medicines - The Role of Manufacture and Supply, David Webber, Fellow and Director of Economic Policy at the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), advocates the removal of barriers and impediments that disadvantage companies in their pursuit of low-cost manufacturing |
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| The global manufacture and distribution of counterfeit products is a growing concern. Timothy Trainer, President of the International AntiCounterfeiting Coalition, Inc., discusses the dangers the industry faces, in Counterfeiting - A Multi-Industry and a Consumer Threat |
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| In Counterfeit Drugs - A Clear and Present Danger, Dr James Rittenburg, Vice President of Technology and Business Development at Biocode, looks at why the design and implementation of pre-emptive brand protection strategies should be viewed as an integral part of the drug development process |
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| Wolfgang Winter, Senior Product Manager of Data Systems at Agilent Technologies GmbH, investigates the role of computer-based regression for computer system validation, in Automated Regression Testing for Computer System Validation |
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| Lean production has become the latest panacea for how manufacturers are to transform themselves into world class operations. Blair McCallum, Head of McKinsey & Company's Production System Design Centre (PSDC) takes a look at the pros and cons, in Making Lean Work - A Holistic Approach Brings Sustainable Benefits |
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| In Containment by Airflow for Highly Potent Materials, Hari Floura, President of Operations for Applied Containment Engineering Inc., outlines the benefits of using isolation technology systems in manufacture |
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| In New Manufacturing Technologies - From Drug Discovery to Final Product, Benjamin Bryant, Global Communications Lead at Honeywell Industry Solutions for Chemicals, Life Sciences and Consumer Goods, explains the value of newer manufacturing technologies |
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| Derek Woodcock, Technical Services Director for Britannia Pharmaceuticals Ltd., looks at the wider roles of pulmonary surfactant, in Surfactant - Therapy, Excipient and Humectant |
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| Maren Friedrich, Scientist at the R&D Department of GELITA Europe, discusses how the Dissolution Performance of Pharmaceutical Hard Capsule Gelatine Films can be used as an important tool to select the optimised gelatine type and quality for the production of hard gelatine capsules |
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| In Options in Materials for Liquid-Filled Capsules, William Bowtle, Technical Director at MW Encap Ltd, describes the current status of various potential substitutes for gelatine two-piece capsules, with particular reference to their suitability for liquid products |
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| The manufacturing of gelatine capsules is an exacting operation that requires specific conditions to ensure the highest quality of the final product. Ing. Koen Egberts, International Sales Manager for Kathabar Systems, guides us through the processes, in Drying Technology - Soft Capsule Manufacturing |
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| Alan Holmes, Sales Manager at Raupack, addresses the challenges that face the packaging and device industry when developing systems for the new generation of micronised inhaler powder drug delivery systems, in Filling Systems for Inhalant Powders - Trends and Challenges |
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| In Advances in Tabletting, Dr John Fell of the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester, and Consultant to Manesty's Process Development Group, discusses advances in the behaviour of materials during compression, excipients and the impact of regulatory authorities in this area |
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| In Developing Custom Adhesive Systems for Transdermal Drug Delivery Products, Melinda Hopp, Director of Marketing at Adhesives Research, Inc., explains how technological advances in adhesives are helping to forge partnerships between adhesives manufacturers and pharmaceutical companies |
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| Daan Crommelin and Gert Bos of OctoPlus and Gert Storm of the Utrecht Institute for Pharmaceutical Sciences, review the use of liposomes in drug delivery, in Liposomes - Successful Carrier Systems for Targeted Drug Delivery |
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| In Liposomes as Drug Delivery Systems, Dr Piotr Slifirski, Head of the Pharmaceutical Department at the Pharmaceutical Research Institute in Poland, outlines the benefits of using liposomes in pharmacy and medicine as carriers of active substances |
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| In recent years, the nasal route has received a great deal of attention as a convenient and reliable method for the systemic administration of several compounds. Pierre Carlotti, Marketing Director at Valois' Pharmaceutical Division, explains why, in Unit-Dose Nasal Sprays - Systemic Delivery Through the Nose |
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| Dr Patricia Lobo, Editor of PMPS, speaks to Colleen Ellis, Martin Atkinson and Benjamin Bryant of Honeywell's Automated Control Solutions Division - Chemicals, Life Sciences and Consumer Goods, about the company's activities, in Speeding Time to Market |
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| In Nutraceuticals Production Standards, Dr Cesare Dognini, Quality Assurance Manager at Fine Foods NTM S.p.A., investigates the standards that need to be observed in order to maintain quality production |
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| In Functional Labels and What they are Used For, Peter Seidl, Sales Manager of Schreiner's MediPharm Business Unit at Schreiner Label and Self-Adhesion Technology, looks at the benefits of labels that are equipped with additional functional features |
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| Developing a containment strategy has become a moving target as the exposure limits for new drug compounds become increasingly low. Henry Rahe, Director of Technology at Containment Technologies Group, Inc., suggests a solution in Containment of Potent Compounds - The New Paradigm |
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| Adrian Simmons, Manager of Security Systems Europe for Westvaco Brand Security, discusses the importance of Shaping a Brand Security Programme at a time when branded global products are at risk from clandestine attack from the illegal trafficking of counterfeit goods |
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| As medical and pharmaceutical science progresses, so must the packaging solutions essential to the task of delivering drugs to the point of use. Stefan Glimm, Secretary General of the European Aluminium Foil Association, endorses the use of Aluminium Foil - A Versatile Tool for Pharmaceutical Packaging |
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| In Pharmaceutical Containers Inspection - Quality Insurance for the Manufacturer, Etienne Botman, Managing Director, and Ludovic Dormal, Sales Engineer at VISIGLAS SA, explore the challenges faced by glass manufacturers working in the pharmaceutical industry |
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| The FDA's June 1999 Container Closure Guidance has accelerated the requirements for extractable and leachable testing of container/closure packaging components. Frances DeGrazio, Vice President of Quality Assurance at West Pharmaceutical Services, Inc., examines The Importance of Leachables and Extractables Testing for a Successful Product Launch |
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| Rebecca Cavalфt of PMPS previews CPhI Worldwide 2002, which takes place between 1st and 3rd October 2002 in France, in The CPhI Worldwide 2002 Conference Preview - Where Science Comes First |
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| Dr Patricia Lobo, Editor of PMPS reviews the final Interphex show which took place in Birmingham between 21st and 23rd May, in Interphex 2002 - A Dedicated Pharmaceutical Event |
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| The Polish pharmaceutical industry has undergone tremendous change over the past 12 years. Wladyslaw Rzycki, Attorney at White & Case explains how the industry is coping, in The Polish Pharmaceutical Industry - Dynamic Growth in a Challenging Legal Environment |
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| In MES or Mess? - The Creation of Management Information and the Effective Use of Production Data in Pharmaceutical Manufacturing, Espen Gisvold, Managing Director of ESGH, analyses the data and information needs of the various participants in the production, delivery and decision processes |
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| Dolores Birlanga, a Managing Head at Caleidos e-Linguistic Solutions, highlights the importance of translation as a selling point when tackling the worldwide market, in If You Want to be Global, You Need to be Local |
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News and Press Releases |
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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?
More info >> |
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White Papers |
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Cleaning Validation: What do you need to consider to ensure a successful outcome?
RSSL
Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
More info >> |
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Industry Events |
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SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019
1-2 April 2019, Holiday Inn Kensington Forum, London
SMi Group are proud to announce the 11th annual Adaptive
Designs in Clinical Trials conference and exhibition will return to London from
the 1st – 2nd April 2019. With the growing popularity in use and acceptance of
adaptive designs in clinical trials - demonstrated most recently with the new
FDA draft guidance on adaptive designs – there is a pressing need for a forum
which explores this increasingly normalized medical methodology.
More info >> |
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