Readying for a US FDA Inspection

Jun 27, 2013

The Federal Food, Drug and Cosmetic Act states that domestic drug establishments can be inspected at least once every two years. The inspections can happen more frequently, such as if the drug you are producing is new, or if your facility has a history of cGMP problems. Joseph Pickett at Expert Briefings provides an overview of what you can expect the FDA inspector to do when he or she shows up. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/Readying-for-a-US-FDA-Inspection.pdf” type=”pdf”]Readying for a US FDA Inspection[/prettyfilelink] ...

Read More

Pharma Serialisation: A New Challenge for the industry

Jun 27, 2013

Serialisation in the pharmaceutical industry is becoming a very important challenge, not only for the manufacturers but also for their packaging suppliers. According to the Directive 2011/62/EU, pharma companies have three years to implement a successful strategy in all their products to be distributed in the European Union. Saul Serrano at Nekicesa looks into similar regulations that are in place today in India, China, Turkey and some other countries. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/3-Pharma-Serialisation-A-New-Challenge-for-the-Industry.pdf” type=”pdf”]Pharma Serialisation A New Challenge for the Industry[/prettyfilelink] ...

Read More

A Highly Secure 2D Code to Protect Medical Drugs from Counterfeiting

Jun 27, 2013

The globalisation of production sites and distribution has led to a boom in counterfeit products and dysfunctions of systems and distribution networks. More and more pharmaceutical laboratories are choosing to go beyond regulation and adopt a new security device: a highly secure 2D code, allowing not only identification, but authentication. Jean-Pierre Massicot at Advanced Track and Trace explains that all sectors are concerned – the pharmaceutical sector included. Laboratories are reacting; authorities are implementing new regulations regarding medical drugs’ identification and authentication. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/2-A-Highly-Secure-2D-Code-to-Protect-Medical-Drugs-from-Counterfeiting.pdf” type=”pdf”]A Highly Secure 2D Code to Protect Medical Drugs from Counterfeiting[/prettyfilelink] ...

Read More

Inner Strength

Jun 27, 2013

Glass has established itself over the years as the most commonly- used primary packaging material for injectable drugs. And yet new drugs and sophisticated production processes such as lyophilisation have given birth to new challenges that high-quality glass containers must face. Florence Buscke at SCHOTT Pharmaceutical Packaging looks into how their geometries and special coatings help to make them stronger and minimise the risk of breakage, but also improve temperature transfer during the lyophilisation process. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/1-Inner-Strength.pdf” type=”pdf”]Inner Strength[/prettyfilelink] ...

Read More

The Future of Pharmaceutical Manufacturing

Jun 27, 2013

According to a recent survey, global annual spending on pharmaceuticals is set to reach almost 1.2 trillion US dollars in 2016. The so-called pharmerging markets play an important role in this development. Growing population, rising incomes, and improved access to drugs are amongst the reasons for these markets reaching 30 per cent of global expenses by 2016. Jérôme Freissmuth at Robert Bosch GmbH explains how rapid development of emerging markets, progress in drug research, the rise in generics production, the availability of high-potency drugs, and innovations in manufacturing processes, will sustainably modify the global pharmaceutical landscape. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/2-The-Future-of-Pharmaceutical-Manufacturing.pdf” type=”pdf”]The Future ...

Read More