Viewpoints

FDA is opening the door to continuous learning in process development.

"It was the late 1970s," reports our GMP-Agent-in-Place, "and we used a primitive desktop computer with built-in teletype for our quality control work.

I rarely talk science on the weekends. I spend a good deal of that free time with friends from college performance groups. The conversation centers more on choreography and piano concerti than on CGMPs and chemical reactions. So it always throws me for a loop when these theater and music buffs drop pharmaceutical news into casual conversation.

Enterprise information integration delivers needed real-time capability to operational business intelligence.

If delaying the project has little consequence then you should probably not run the project in the first place.

It's all well and good providing drugs for people who need them, but it becomes a lot more difficult if they choose to ignore the warnings

Is the lack of finance necessarily spelling doom for the European biotech industry?

Will we be innovative enough if we just become service providers?

Is the recent round of Big Pharma plant closings a sign of regrowth?

It's time for the pharmaceutical industry to consider electronic innovations as part of their life cycle management strategies.

A particular dermatological product was packaged in a metal tube, which is filled from the bottom.

This year's fall conference season clearly shows that the new, systematic approach to process planning and product quality is permeating the industry's thinking—if not yet its daily practice.

A new oral dosage product was designed as "encapsulated tablets." In production, the drug product was pressed into tablets, which were then fed into a revolving capsule-filling table.

If judges and juries lack the scientific knowledge to decide drugsafety cases, how can we protect both companies and patients?

First, a confession. Yes, the four sleep-deprived editors hunched behind glowing laptops in the Opryland Resort's Cyber Café last month were indeed from this publication. Normally, our mumbled conversations about punctuation and grammar take place before 11:00 pm—and under slightly lower systemic levels of caffeine, sugar, and sushi.

The attraction of nasal administered therapeutic agents is obvious, including faster onset of action, increased compliance and avoiding degradation during first pass metabolism.

"It was just after FDA had initiated the Pre-Approval Inspection process," reports our GMP Agent-in-Place.

Oddly for a technical meeting, the Oct. 5–7 AAPS Workshop on Pharmaceutical Quality Assessment focused on words, with an entire session devoted to definitions and countless discussions of meaning and nuance.

As industry moves to real-time feedback control, even conventional syntheses will increasingly resemble living systems.

The pharmaceutical industry can leverage best practices from the extremely competitive semiconductor market.

Recent advances in transdermal technologies challenge the paradigm that only a few drugs can be delivered transdermally.

The EU ATEX Directive 1999/92/EC (ATEX 137) regarding the minimum requirements to protect the health and safety of workers potentially at risk from explosive atmospheres came into European law in January 2000. In the UK, the ATEX 137 Directive has been implemented as part of the Dangerous Substances and Explosive Atmospheres Regulations (DSEARs), which were issued in December 2002.

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

Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.

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

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

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!

Essentially, RAD is a set of tools…that allows for rapid prototyping and reiterative testing that enable faster development and implementation of new applications.

The pharmaceutical science education system must be transformed.