Articles

Webcast: An Off-the-Shelf SAP and E-Pedigree Solution for Small and Midsize Pharmaceutical Companies

This webcast, sponsored by IdhaSoft and SAP, will share information, ideas and case study experiences for improving operational efficiencies, reducing time to market and maintaining e-pedigree compliance.
Post Date: 06/30/2009
Author:

Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing

Acknowledged by the FDA as an advanced aseptic process for the packaging of sterile pharmaceutical liquids, blow-fill-seal technology is gaining increasing acceptance by providing a high assurance of product sterility, eliminating the need for human intervention, improving flexibility in container design and ...
Post Date: 06/25/2009
Author: Chuck Reed, B.Sc/MS Director, Sales & Marketing, Weiler Engineering, Inc.

From the Editor: H1N1, Shamanism and Shame

Thirty-three years after the last “Swine flu” scare, we still cannot seem to make flu vaccine and antiviral manufacturing any more predictable. Are today’s solutions like amulets whose power cannot last?
Post Date: 06/18/2009
Author: Agnes Shanley, Editor in Chief

The Impact of Inventory Turns on Speed, Quality, and Costs

By creating low inventory environments, pharma can establish the “Leanness” that it sorely lacks.
Post Date: 06/17/2009
Author: Robert E. Spector, Principal, Tunnell Consulting

Pfizer's Gabapentin Goes Green

Pfizer Singapore site leader Stella Eccles talks about making gabapentin (Neurontin) green, and keeping it viable.
Post Date: 06/17/2009
Author: Paul Thomas, Senior Editor

Digital Insights: Online Video & Bikini Girl Inspirations

Former Merck employee turned viral video genius tells the world, “Don’t just get a job, do what you love.”
Post Date: 06/17/2009
Author: Michele Vaccarello Wagner, Senior Digital Editor

Eluding the OpEx Black Hole

When it comes to operational excellence initiatives, middle managers are often seen as the problem—a black hole, if you will—but can be the solution.
Post Date: 06/17/2009
Author: Paul Thomas, Senior Editor

The Few, the Proud, the Certified

ISPE’s Certified Pharmaceutical Industry Professional (CPIP) certification program is (as it should be) only for those who enjoy a challenge.
Post Date: 06/17/2009
Author: Paul Thomas, Senior Editor

Speeding Time to Clinic With GMP Knowhow and High Throughput Screening

As Big Pharma changes its outsourcing model, Symyx eyes opportunity.
Post Date: 06/15/2009
Author: Agnes Shanley, Editor in Chief

Therapeutic Dose: Beam Me Some Data, Scotty!

The satellites are up there; why not use them for anticounterfeiting?
Post Date: 06/10/2009
Author: Emil W. Ciurczak, Contributing Editor

FDA’s Process Validation Guidance Calls for Technology Solutions

The draft guidance is a win-win-win: good for FDA, consumers, and manufacturers.
Post Date: 06/10/2009
Author: Justin O. Neway, Ph.D., Aegis Analytical Corp.

Process Validation Guidance: Light at the End of the Tunnel

Those who embrace the new process validation guidance may separate themselves from those who do not.
Post Date: 06/10/2009
Author: Bikash Chatterjee, Pharmatech Associates

Ensuring ROI from Your RMM

If you’re heading towards the adoption of rapid microbiological methods, you’ve got to be able to make a business case.
Post Date: 06/10/2009
Author: Michael J. Miller, Ph.D., Microbiology Consultants, LLC

Value-Adding Valves

From plant to process, having the right valve in place, and healthy, can save time, energy, money and, yes, headaches.
Post Date: 06/05/2009
Author: Paul Thomas, Senior Editor

LEAN and Six Sigma: Sustaining Gains Throughout the Product Lifecycle
In this webcast, companies that are in Lean Six Sigma for the long haul share best practices and the financial results that you can expect. They also address how to get management buy-in for programs that will withstand the test of time.
Post Date: 06/05/2009
Author:

USP Updates <61> and <62> for Microbial Testing of Non-Steriles

The United States Pharmacopeia (USP) has significantly changed the USP XXXI <61> Microbial Limits Test, updating it and dividing it into two parts
Post Date: 06/04/2009
Author:

Putting Global Manufacturing Data at Your Fingertips

Implementing a new IT paradigm for on-demand data is as much an organizational issue as it is a technological one.
Post Date: 06/02/2009
Author: Justin O. Neway, PhD, Aegis Analytical Corp.

As Owings Mills Closes, Can Shire Do Right By Workers?

The closing of a facility is a chance to gauge the commitment of a company.
Post Date: 06/02/2009
Author: Paul Thomas, Senior Editor

Therapeutic Dose: Troubles with Outsourcing?

Maybe you’re just too “far out” and should look closer to home.
Post Date: 06/02/2009
Author: Emil W. Ciurczak, Contributing Editor

Digital Insights: Web 2.0 on the Trail of the Swine Flu

The Google/Twitter map, and applications like it, promise to help the drug industry respond to emerging crises
Post Date: 06/02/2009
Author: Michele Vaccarello Wagner, Senior Digital Editor