Articles

Cleaning Agent Residue Detection with UHPLC

The productivity potential of ultra-high-performance liquid chromatography is a “clean” cut case
Post Date: 04/26/2013
Author: Michael Gietl, Brook Meadows and Paul Lopolito, Steris corp.

Good Vibrations

Respondents to Pharmaceutical Manufacturing’s 9th annual job satisfaction and salary survey find the industry is beginning to hit a few more high notes than last year
Post Date: 04/26/2013
Author: Steven E. Kuehn, Editor in Chief

Continuous Chromatography as a Downstream Bioprocess Tool

Either true or simulated, moving bed chromatography has real potential to speed the flow downstream
Post Date: 04/23/2013
Author: Emil Ciurczak, Contributing Editor

How to Optimize Continuous OSD Manufacturing

The opportunities are there and an experienced integrator can often make it happen
Post Date: 04/16/2013
Author: Hector T. Davila, Director Process/Specialty Engineering, Fluor

Coming of Age

It’s been 10 years since the FDA released Pharmaceutical GMPs for the 21st Century, but it’s likely the next 10 that will shape the industry for decades after
Post Date: 04/10/2013
Author: Angelo DePalma, Ph.D.

Hiding the Costs of Outsourcing

Be sure to weigh all of the pros and cons as well as ROI before making the decision to outsource
Post Date: 03/20/2013
Author: Emil Ciurczak, Contributing Editor

Weighing the Benefits of Scale Equipment

When it comes to pharmaceutical manufacturing, every machine, component and piece of equipment must work in unison
Post Date: 03/18/2013
Author: Louis Alonzo, Territory Manager, Avery Weigh-Tronix

Framework for Fast Microbiological Assessment

Encyclopedia of Rapid Microbiological Methods, Volume 4: The Next Generation of Rapid Method Applications, Validation Strategies and Regulatory Acceptance
Post Date: 03/14/2013
Author: Michael J. Miller, Ph.D.

The Case for Global Supply Chain Standards

Agreement around common supply chain standards and supporting processes could revolutionize the healthcare sector
Post Date: 03/13/2013
Author: Thomas Ebel, Katy George, Erik Larsen and Ketan Shah, Mckinsey & Co.

Ins & Outs of Tech Transfer

Best practices for one of oursourced manufacturing's tougher challenges
Post Date: 03/13/2013
Author: Angelo DePalma, Ph.D.

Uncommon Sense in Execution of Process Simulations

There are a number of areas where interpreting published information and applying it in the real world has proven to be problematic.
Post Date: 03/11/2013
Author: James Agalloco

Focus on Efficiency

Single-use, analytical methods and downstream processing at the forefront.
Post Date: 03/06/2013
Author: Eric S. Langer

6 Tips for Mitigating Manufacturing Risk

Medical device manufacturers partner with contract manufacturers to identify potential risks and help produce safe, reliable, high-quality products
Post Date: 02/13/2013
Author: Leigh Toole

Ask the Right Stats Questions to Find the Best Statistics Tools

Once you know what the objective is and what the need is, you can figure out which tools can help meet your objectives
Post Date: 12/18/2012
Author: Ronald D. Snee, PhD, Snee Associates

Holiday Inspiration from Takeda's EVP, Tadataka Yamada

Become partners with emerging markets, in the broadest sense, he said, and always support, and embrace, revolutionary, rather than evolutionary change.
Post Date: 12/11/2012
Author: Agnes Shanley, Editor in Chief

cGMP Judgment Day

A look at recent FDA enforcement activities and lessons to be learned.
Post Date: 12/03/2012
Author: Agnes Shanley, Editor in Chief

From the Editor: The Long Arm of Lean

Lean’s influence is being felt far beyond the plant floor, but there’s still a long way to go.
Post Date: 10/10/2012
Author:

Through the Lens of Lean

Lean may have been designed for manufacturing, but it can also transform QC labs, as this case study shows.
Post Date: 10/03/2012
Author: J. Paul Catania, Tunnell Consulting

Lean in the Lab: Build it Right, and It Will Come

How Pfizer applied traditional concepts in an untraditional way
Post Date: 09/20/2012
Author: Kristin Zevitas, director, global quality business processes, Pfizer Global ...

Estimating Risk-Based Cost and Contingency

How to Apply Monte Carlo Simulation to Engineering Capital Projects
Post Date: 09/05/2012
Author: Keith Melchiors