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Pharmaceutical Manufacturing and Packing Sourcer

Industry Insight

Given that it is summer and many of us are enjoying warm climates and higher temperatures, it seems somewhat appropriate that issues around cold chain supply are a focus of this latest edition.

With PDA Europe’s Pharmaceutical Cold and Supply Chain Logistics conference approaching, Co-Chairs Erik van Asselt and Rafik Bishara outline the various topics up for discussion at this year's event (page 30). We also hear from Hans Börjesson at Starbright and Gabriel Andersson at Envirotainer, who present a case study on how temperatures can be monitored by telemetry – although, as they point out, this technique has not been widely applied for pharmaceuticals (page 40).

Describing the use of temperature-controlled environments during the production, packaging and distribution of medicines, PCI's Tim Roberts considers the many benefits beyond ensuring drug efficacy (page 62). In particular, he explains that companies are beginning to evaluate temperature-controlled packaging as part of study design – choosing minimal risk while achieving maximum efficiencies, and ultimately delivering a safer product faster.

In light of the recent World Cup in Brazil, it is perhaps fitting that we look at Latin America in this edition too. Analysing this growing market, Shanshan Wang at Business Monitor International forecasts that by 2023, medicine expenditure in this region will account for more than 11% of the global drug market – up from 6% in 2005 (page 16).

However, she warns that as foreign drug-makers deepen their ventures here, pharma companies will become more exposed than ever to local political and macro-economic changes.

These sentiments are echoed by Sue Lee of World Courier, who highlights some of the regulatory frustrations that occur when carrying out R&D and marketing of products in Latin American countries (page 74). Local knowledge is vital, she says, and finding partners that understand the intricacies of specific geographies and cultures is an often overlooked component of a successful clinical trial or product development.

In the developing world, counterfeit pharmaceuticals can be rife, but this problem also exists in Europe, as Daniel Rossek at Omron Electronics points out (page 56). Through the Falsified Medicines Directive (FMD), EU regulators are ushering in a new era of pharma manufacturing and distribution compliance that is expected to tighten up supply chain safety and eliminate false medicines.

Being able to consistently meet the FMD's requirements is imperative for pharma manufacturers. The direction and shape of the post-2017 EU pharma supply chain is clear – if the changes mandated by the directive are not acted upon, there is a real danger that some companies will not be able to trade in Europe.

This topic is taken further by Kelly Wrich and Chris Bishop from 3M Drug Delivery Systems (page 24). Looking at the legislative push to implement global anti-counterfeiting solutions, they report that the pharma industry is under increasing pressure to adopt serialisation measures to improve patient safety as part of track and trace procedures. Such moves are thought to be a positive step forward and, once incorporated, will offer better protection for products. However, global integration of the necessary requirements will take time, and the industry should ultimately keep in mind the possibility of a transition to a common global standard.

Cold chain, Latin America and counterfeiting are developing issues that look set to stay on the pharma radar for quite some time, and we hope that these and the remainder of the articles in this summer edition keep you informed and enlightened.

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