Mark McClellan on Pharma’s Role in U.S. Health Care System
Speaking at a Sept. 19 conference at Glatt Pharmaceutical Services, former FDA Commissioner Mark McClellan reminded pharma manufacturing professionals why their work is a critical part of the national health care debate.

Building a Business Case for PAT
Securing the support of upper management is essential to the successful implementation of Process Analytical Technology projects. Here, the authors provide a how-to guide.

A Synthesis of Cultures
When executives at Samchully Pharmaceuticals Co. Ltd. (Seoul, Korea) sought out the machinery they would need to expand their oligonucleotides business, they got more than steel and tubing. They forged a trans-global relationship with a U.S. equipment supplier that is introducing them to PAT.

From the Editor: Rx for the Industry: Manufacturing Research
More concerted research efforts are needed to advance drug manufacturing, wherever it takes place.

Therapeutic Dose: How Can I Miss You If You Won't Go Away?
Our 'humble narrator' offers a counterpoint to last month's column on oursourcing; here, he makes a case for telecommuting.

How Part 11 Compliance Impacts QbD
No longer stuck with the "validate everything" mantra, companies now need to assess the risks applicable to their electronic information and integrity to determine what (if any) validation is needed.

Leaning on NIR in Pisa
Italian drug maker Abiogen Pharma S.p.A. has succeeded in saving time and money as a result of applying near-infrared spectroscopy to raw materials characterization.

Conductivity Measurement: Critical for Clean-In-Place Systems
Measuring high concentrations of acid and caustic, as well as purified rinse water, is necessary for CIP conductivity analysis. The process is becoming easier.

QbD: An Interim Report Card
The industry and FDA must move towards a cohesive message and methodology to realize the full benefit of QbD.

Optimizing Cleanliness & Drainability
Owners face the prospect of losing millions of dollars each year because of improperly sloped process lines and entrapment in valves and fittings.