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PUBLICATIONS

Pharmaceutical Manufacturing and Packing Sourcer

pmps
Winter 2015

   
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Industry Insight 
Industry Insight

Consultant Editor Graham Hughes draws attention to the global problem of counterfeit medicines – a focus topic for this edition – and shares his views on the efficiency of inhaled drug delivery.
 
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Cool Chain, Cargo & Logistics
Q&A: Biopharma Logistics

No Such Place As Far Away


Biopharmaceutical transportation is far from straightforward, but Sue Lee at World Courier tells PMPS why she thrives within this vibrant, versatile industry.
 
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Roundtable: Cool Chain Integration

All Together Now


Cool chain logistics is a complex but crucial part of the pharma industry. At a roundtable discussion held last year by the Cool Chain Association – attended by a number of its board members and other interested parties – supply chain integration was the main talking point.
 
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Anti-Counterfeiting
Coding Compliance

Print Ready


With the Falsified Medicines Directive requiring manufacturers across Europe to upgrade their production lines to accommodate more sophisticated coding systems, Rotech’s Richard Pether suggests an alternative offline solution.
 
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Pharma Serialisation

On the Brink of Extinction?


The three-year implementation period for the Safety Features regulations in the EU’s Falsified Medicines Directive is due to commence in 2015. Ian Haynes of 3C Integrity Consulting asks: will failure to comply trigger a mass extinction event within pharma?
 
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Supply Chain Visibility

Eyes Wide Open

A complete end-to-end view of the entire supply chain – achieved only through creating high levels of collaboration – is essential if pharma businesses are to meet serialisation legislation, argues Diane Palmquist at GT Nexus.
 
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INHALATION
Inhaled Drug Delivery

The Time Has Come


No longer a niche area, inhaled drug delivery is expanding into many new indications, products and markets. Gonçalo Andrade, Peter Villax and Carla Vozone from Hovione comment on the current trends within the sector.
 
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Generic DPIs

Best Tool for the Job


Dr Paul Kippax
of Malvern Instruments considers the recent interest in developing generic inhaled products, but acknowledges that they present a significant deformulation challenge. A new tool in the form of morphologically directed Raman spectroscopy may hold the answer.
 
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PACKING & PACKAGING
Desiccant Adsorption

Pharma Without the Fudge Factor


A new predictive modelling system offers an alternative to the guessing games inherent in today’s desiccant behavioural studies, explains Dr Mark Valentine from Baltimore Innovations.
 
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Child-Resistant Packaging

Leading the Way

Consumer-led design is the best way for manufacturers to offer the most competitive drug packaging. Hung Le at MWV believes that when patients have a good experience with their medication package, it can help create a more positive overall outlook on their healthcare.
 
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PREVIEWS & REVIEWS
Event Review

High Standards


Speakers at PDA Europe’s recent Pharmaceutical Cold and Supply Chain Logistics Conference debated supply chain visibility, product integrity and industry best practices. Co-Chair Erik van Asselt reports.


 
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Book Review

Common Knowledge


In Generic: The Unbranding of Modern Medicine, Jeremy A Greene provides insight into the evolution of the generic drug industry. Graham Hughes reflects on the book’s strengths.
 
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MARKETPLACE & BUSINESS
Q&A: Clinical Services

Onwards and Upwards

PCI’s Tim Brown
reveals what he loves best about working for the Clinical Services team, as well as discussing how the recent popularity for self-administration and self-monitoring supports a growing demand for companies to demonstrate patient adherence to their drug products.
 
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Second-User Equipment

Every Penny Counts


Once the remit of cash-strapped start-ups, purchasing of second-user equipment is now on the rise – even among global, multi-facility pharma giants. EquipNet’s Ben Potenza shares his golden rules for companies considering this route.
 
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MANUFACTURING & PROCESSING
Compressed Air

Pure and Simple


Sometimes referred to as the fourth utility, compressed air plays a vital part in manufacturing operations. But it is vulnerable to contamination, and this can come from many different sources. David Whelan at IMI Precision Engineering offers his thoughts on today’s purification technologies.
 
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Data Management

Bigger and Better

Alan Johnston
at Siemens UK & Ireland outlines the essential role data plays within pharmaceutical manufacturing, and encourages companies to keep watch on the latest technology trends in order to boost product safety and efficacy.
 
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Temperature Control

Scale Up


Temperature controller calibration can improve system efficiency and product quality, but is often under-utilised by pharma manufacturers. Ian Parnell of West Control Solutions highlights the reasons why they should be paying more attention to modern features.
 
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The End of the line
The End of the Line

Just A Phase

In recent years, the uptake of phase change materials for use in thermal packaging has been considerable. Richard Harrop believes that this is more than just a fly-by-night trend.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

SHIONOGI LAUNCHES FETCROJA® (CEFIDEROCOL) IN THE UNITED KINGDOM FOR THE TREATMENT OF INFECTIONS DUE TO AEROBIC GRAM-NEGATIVE BACTERIA IN ADULTS WITH LIMITED TREATMENT OPTIONS


More info >>

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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