Pharma IQ Members

Supply Chain Security – Track & Trace
264 results
of 24
Contributor: Chanice Henry
Posted: 07/14/2017
Chan
The FDA has published draft guidance proposing a 12 month grace period on the enforcement of November’s DSCSA ( Drug Supply Chain Security Act) requirements.  Even still the industry should continue serialization projects to secure supply chains ahead of 2017's deadline.The US Food and Drug Administration is planning to postpone taking action Full Content »
Contributor: Joe Whyte
Posted: 07/13/2017
rockwell WP
Global pharmaceutical companies lose an estimated $75 billion annually to prescription drug counterfeits — not including costs of diminished brand value. Impending government regulations will require comprehensive serialization elements not just in your manufacturing facilities, but also across the supply chain.The challenges stand tall in ser Full Content »
Contributor: Andrew Love
Posted: 06/29/2017
Andrew Love
For many pharma companies, the use of contract manufacturing organisations (CMOs) to package commercial product is an integral part of their supply chain. Indeed, for virtual companies, it may be the only way their products are packaged. Serialization legislation in the US, EU and many other countries means that, without the successful and timely i Full Content »
Contributor: Pharma Logistics IQ
Posted: 06/15/2017
serialization
The end of 2017 is peppered with compliance deadlines for the track and trace industry as it joins the combat against counterfeit pharmaceuticals. These regions include the likes of Canada, the US and Ukraine. Despite the urgency, many medicine manufacturers in the industry have been labelled as behind schedule.With time running Full Content »
Contributor: Pharma Logistics IQ News
Posted: 06/05/2017
Optel
OPTEL GROUP, a leading global provider of traceability systems for the pharmaceutical and medical device industries, announced today that it officially inaugurated its new manufacturing facilities in Campinas, Brazil.After a successful expansion at its Canadian headquarters, as well as recent sites in Ireland and India, OPTEL is very pleased to add Full Content »
Posted: 03/30/2017
World beyond compliance
Whilst it is natural for a serialisation program to focus on delivering to the hard legislative deadlines, it can be detrimental if these short term needs limit the project’s long term scope and capabilities. If this is allowed to happen, then reaping the broader future benefits from the serialisation project may prove to be signific Full Content »
Contributor: Pharma IQ
Posted: 03/23/2017
Traceability in Operations
Ahead of the traceability in operation forum 2017 Pharma IQ conducted some market research to pinpoint the concerns and priorities of those in the more mature phases of serialisation. Commentary is supplied by Pasi Kemppainen, Executive Consultant, Pharma Serialization and Traceability.In the research almost 30% of respondents stated that impl Full Content »
Contributor: Pharma Logistics IQ
Posted: 02/07/2017
UDI complexities
As the US ploughs ahead with its UDI regime, the EU’s launch of Medical Device Regulation (MDR) draft documents last year helped progress industry understanding. However, a lot of uncertainty remains regarding the European UDI landscape. On average, a selection of experts have highlighted one k Full Content »
Contributor: Pharma Logistics IQ News
Posted: 12/21/2016
Cold Chain IQ News
The world of Pharma Logistics didn't take its foot off the gas as the year drew to a close. The fourh quarter of 2016 saw prospects grow stronger for the launch of a debut composite refridgerated trailer in North America, new guidelines from the EMA and an investigation into a suspected pharma supply chain breach. Growing support for debut com Full Content »
Posted: 12/01/2016
Tracelink, FMD, Serialization, serialisation, EU, Brexit, pharma, supply chain, falsified medicines,
If you’re just beginning your EU FMD compliance journey, this guide is for you. The EU Falsified Medicines Directive is full of detail and complexity—and you’ll need to know the ins and outs of the regulation long before the February 2019 compliance deadline. Our experts break everything down for you so you can be informed—and ready Full Content »
Contributor: Andrew Love
Posted: 11/24/2016
Andrew Love
In the previous article we looked at the development of standard solutions, the need for appropriate levels of resourcing, provision of the right leadership and the need to stay abreast of the continually evolving legislation.  In this, the final article in this series, we look at the remaining three learning points – the involvement of local Full Content »
264 results
of 24