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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Autumn 2015

   
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Industry Insight 
Industry Insight

Industry efforts to ensure the supply of effective medicines – whether it be tougher measures to combat counterfeits, better cold chain standards, or quality management priorities – are explored in this edition's PMPS. Industry Advisor Robert Harris provides an introduction.
 
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Cool Chain, Cargo & Logistics
Temperature-Controlled Packaging

Up to Standard?

The move to large molecule medicines calls for greater reassurance of temperature-controlled packaging reliability. Richard Wood of Peli BioThermal calls for a new industry-wide standard performance measure to help bring speed and simplicity to supply across challenging shipping routes.
 
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Packaging TCO

At All Cost

CSafe Global's Brian Kohr
argues for a total cost of ownership approach to steer temperature-controlled packaging decisions. The entire supply chain process – from packaging engineering and operations through to logistics, quality and end-use – should be assessed and wider stakeholder input sought.
 
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Drug Delivery 
Nasal Drug Delivery

Nosing Around

Gerallt Williams from Aptar Pharma describes how the benefits of unit and bi-dose nasal and sub-lingual spray devices – notably, their wide therapeutic range and ability to improve safety and adherence – make them well-placed to tackle the problems currently surfacing within the drug delivery space.
 
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Auto-Injection Devices

Patients Come First

Jochen Ratjen
of SHL Group identifies the key considerations for device designers of self-administered injections. While human factors engineering is a central preoccupation and source of inspiration, creative ideas must not neglect manufacturing feasibility.
 
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Pre-Filled Syringes

Case in Point


Pre-filled syringes contain various properties and performance requirements needed for appropriate functionality. In light of recent research and regulations, William Dierick and Hideaki Kiminami from Terumo explore changing priorities and device developments.
 
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Labelling 
Product Blinding

Behind the Mask


As rules and regulations for clinical studies pile up for packaging manufacturers, Frank Jäger at Faubel explores how, through innovative blinding and labelling techniques, guidelines can be met head on for the greater benefit of consumers, CROs and pharma companies.
 
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MANUFACTURING
Spotlight

Tightly Sealed


Vial-based parenterals are closed with a rubber stopper before being crimped with an aluminium cap. Datwyler Sealing Solutions outlines the flip caps that are an essential feature, which are shaped through separate manufacturing processes before being mechanically assembled to make one product.
 
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Tablet Tooling

Formulating a Fix

Rob Blanchard of I Holland reviews the physical variables that cause problems for tablet pressing. While persistent tooling issues do arise, a thorough review of tablet features, factoring in formulation, can go a long way to ensuring the production of robust products on a grand scale.
 
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Anti-Counterfeiting
Serialisation Legislation

Challenging Counterfeits

Incoming serialisation requirements will no doubt place big compliance burdens on the industry, but in the longer term will replace forgery with transparency – and open the door to genuinely personalised medicine. Gaurav Banerjee, Rick Seibert and Jonathan Laverick at Sharp Packaging Solutions report.
 
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PREVIEWS & REVIEWS
Event Review

Flying Start

Reflecting on the success of the inaugural FlyPharma Conference, co-organised by PMPS, Alan Kennedy at PartnerSave Ltd highlights the key take-home messages from September’s event,  which probed the need for highly responsive, increasingly cohesive supply chains.
 
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MARKETPLACE & BUSINESS
Regulatory eSubmissions

Switching to Electric


eSubmissions are becoming a way of life, not only from a regulatory standpoint, but also in terms of efficiency. Darryl Clarke at Sciformix Corporation considers the new systems, processes and skillsets that come with the increased take-up of electronic Common Technical Document software.
 
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CMO Quality Management

Level Best

Pushing for a rethink of the industry's use of quality management, Jim Grigg, Nikhil Patel, Joely Rigby and Penny Lisney from 3M Drug Delivery Systems make the case for a Lean Six Sigma approach to achieve product and service quality – driving operational excellence and continuous improvement.
 
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DIGITAL Supply Chain
Digital Signing

Access Denied

Those who fail to adapt to the digitalisation of the modern age do so at their own peril, warns Thales e-Security's John Grimm. Resistance to change will leave pharma and healthcare organisations sidelined, and unable to exploit the advantages to be seized through automating formerly manual processes.
 
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Cyber Security

Digital Warfare

Neil Oliver of Accutronics states the case for protecting hardware against the worrying threats cyber criminals pose to medical and pharmaceutical systems. Encoding efforts to ensure equipment is safe and secure is now a vital first line of defence against impending healthcare hacks.
 
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

Published quarterly in
February, May,
August and November

News and Press Releases

York Health Economics Consortium offers a new health utilities training course

Cost-utility analysis is a requirement for NICE health technology appraisals and is being increasingly used in other contexts and countries. Health utilities, a crucial component of cost-utility analysis, capture the relative change in health-related quality of life resulting from a treatment. As such, health utility can be a key driver of the cost-effectiveness ratio. Obtaining health utility values that are suitable for your economic evaluation, however, may not always be straight forward.
More info >>

White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
More info >>

Industry Events

LogiPharma Europe 2018

10-12 April 2018, Montreux Music & Convention Centre

Now in it’s 18th successful year, LogiPharma is the largest global end-to-end supply chain event for pharma supply chain leaders, their teams and service partners.
More info >>

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