It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.

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Italians are known for their passions. They are passionate about their food, their wine, their art, their design, and in Bologna, they are passionate about their packaging industry. And well they should be. In a time of economic crisis, Italy’s packing industry seems extremely healthy, based on the statistics offered last week by Dr. Guido Corbella, at the Pharmintech exhibition.
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Spring is in the air, and it’s time for a trip to the Javits Center for the annual INTERPHEX conference and exhibition. The editors of Pharmaceutical Technology and BioPharm International have arranged a series of interviews during the conference. We’ll be talking to pharmaceutical professionals, information-technology experts, and regulators about current challenges in manufacturing and about what the future might bring. Read more »

Pharmaceutical supply-chain managers have yet another item to step up their control of: tractor-trailers. A critical part of the delivery of supply, these large trucks have been used by many pharmaceutical companies for years to transport raw materials, ingredients, and final drug products. Cargo theft has always been a concern, but that concern is now growing. Read more »

I have just returned from an event in France which, I have to say, really impressed me. Not because I had the perfect excuse to visit Paris for a couple of days (although that was undoubtedly a bonus), but because I was so impressed by the calibre of presentations and new innovations that were showcased from this relatively small meeting. Read more »

Hands up those of you who read the labels on your medication bottles ‘every’ time you’re due to administer a dose? Not many of you I bet. While much publicity highlights the dangers of counterfeit drugs (and rightly so), what about the dangers linked to incorrectly taking genuine medication? Read more »

Last week, Alexis Pellek of Pharmaceutical Technology wrote about a pilot project launched by the European Federation of Pharmaceutical Industries and Associations to test a new system designed to battle counterfeit drugs (See the blog post.) The system involved using DataMatrix 2D barcodes, which enable pharmacists to test the legitimacy of each packet.

We spoke with Mark Beauchamp, European Marketing Manager of Citizens Systems Europe, a firm that specializes in barcode technology, to better understand how barcoding can help the pharmaceutical industry to clamp down on counterfeit drugs. Read more »

This week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »

The US Food and Drug Administration announced yesterday it is requiring a black box warning for two drugs used to aid smoking cessation, Chantix (varenicline, Pfizer, New York) and Zyban (bupropion, GlaxoSmithKline, London). Read more »

Yesterday, Thomas Lavery, 63, of Irvine, California, was sentenced to four years and four months of incarceration to be followed by three years of supervised release by the US District Court in Concord, New Hampshire, for his involvement in a prescription drug diversion case, according to a court release. Read more »