All News


The human race will have colonized Mars long before the pharmaceutical industry brings itself into the 21st century.

i1-221168-1408689816394.jpg

A range of insect exterminator equipment has been developed to improve the level of hygiene offered to the pharmaceutical and chemical manufacturing sectors. Berson's Insectron range uses ultraviolet (UV-A) and green light to attract flying insects, which are sensitive to these light sources.

i1-185840-1408688292961.jpg

The US Food and Drug Administration (Rockville, MD, www.fda.gov) released a new draft guidance that may speed generic approvals. The guidance, ANDAs: Impurities in Drug Products, describes the degradation-product information that generic drug manufacturers should include in their abbreviated new drug applications (ANDAs). This clarification, FDA officials say, will help companies submit the correct information, thus increasing the likelihood that their generic drugs will be approved, and approved more quickly.

i1-185838-1408688303077.jpg

Confronted by a challenge as vast as Hurricane Katrina, we reach for military organizations for aid and military language for description.

i1-185847-1408688230346.jpg

It was, our GMP Agent-in-Place recalls, a typical, small, clinical-type facility... managed in the typical, informal way.

i1-185849-1408688220417.jpg

API Sourcing

As overseas sourcing arrangements become more and more common, it may be time to look again at the advantages of having suppliers closer to home.

One of the most important skills any editor must possess is the ability to listen to their audience — without feedback, we don't get an opportunity to develop our publications; to not act on feedback shows plain ignorance. I must, therefore, give my personal thanks to the many hundreds of readers who participated in the Pharmaceutical Technology Europe (PTE) editorial and readership survey, which we conducted earlier this summer. Your comments and opinions will help us develop PTE, and we already have a number of exciting plans for 2006. Stay tuned!

i1-182996-1408680981782.jpg

Adding Braille to pharmaceutical packaging should be less of a challenge with the use of Esko-Graphics' Scope solution. EC Directive 2004/27/CE requires Braille labelling and information to be provided with pharmaceutical products for human use, and companies are scrambling to implement this by 31 October.

The US National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www3.niaid.nih.gov) announced it will order two million doses of an avian influenza vaccine from Sanofi-Pasteur (Swiftwater, PA and Lyon, France, www. sanofipasteur.com). In April, the NIAID began a Phase I trial to evaluate the vaccine’s safety and ability to generate immunity against the H5N1 strain of avian flu, an illness that leads to severe disease and possible death in birds and humans.

Wash. Rinse. Repeat

Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer.

i4-176022-1408685673564.gif

Manufacturers of pharmaceuticals and nutraceuticals can protect their products from moisture and other elements while also enhancing marketability, by adding scent to their packaging. The full line of scented packaging solutions, offered by Süd-chemie, is reported to be ideal for applications that emit an unappealing odour to end users. The packaging can also enhance the marketability of odourless products. The flagship product in the scented solution line is Aroma-Can — a product modelled after the company's desiccant canisters. One-gram canisters will be available in orange and lemon scented variations, and can be inserted at the same high rates of speed as traditional desiccant canisters using standard canister insertion equipment.