Articles

From The Editor: First, Do No Harm

Modern control is the best way to ensure patient safety (and corporate survival).
Post Date: 02/01/2012
Author: Agnes Shanley, Editor in Chief

Studying Outliers to Ensure Ingredient and Product Quality

Out-of-trend results from APRs offer unique insights into ingredients and finished products.
Post Date: 01/31/2012
Author: Bir (Barry) Gujral and Peter Amanatides, Noven Pharmaceuticals

PharmaView: Fake Drugs: Why Business is Booming

It’s time to make counterfeiting less economically tantalizing.
Post Date: 12/14/2011
Author: Paul Thomas, Senior Editor

QbD: Redefining Time to Market

For manufacturers who lack formulation and process knowledge, the benefits of getting to market fast can be outstripped by the costs of unexpected failures.
Post Date: 12/06/2011
Author: J. Paul Catania, Tunnell Consulting, Inc.

Ali Afnan: Pharma Faces a New Year: Will it Mirror, or Break Away From, the Past?

Effective change must improve business performance, and not just a process.
Post Date: 11/16/2011
Author: Ali Afnan, PhD, Principal, StepChange Pharma, Inc.

Industry Thought Leaders Share Visions and Lessons about Quality for Innovation and Continuous Process Improvement


Post Date: 10/28/2011
Author: Justin O. Neway, Ph.D.

Win-Win Audits

Customer audits can elevate a relationship, improve product quality, and lower costs for both parties.
Post Date: 10/24/2011
Author: Michael Boetzkes, Quality Manager, Life Science, Vaisala Canada Inc.

Therapeutic Dose: Time to Extrapolate QbD?

Preformulation, formulation and stability testing are all embracing QbD.
Post Date: 10/04/2011
Author: Emil W. Ciurczak, Contributing Editor

Quality: Toward a Multidimensional View

Pharma Tech Industries’ Preston Wright talks about the need to move to a “consistent quality presence that is both efficient and effective.”
Post Date: 09/28/2011
Author: Paul Thomas, Senior Editor

Risk Management in Pharmaceutical Microbiology

At look at how HACCP and FMEA can make a difference in the pharma micro lab.
Post Date: 09/21/2011
Author: Tim Sandle, Head of Microbiology, Bio Products Laboratory

Afnan's Letter from Japan: Japanese Pharma's Embracing PAT, QbD and Opex Tools

As its auto industry has done, Japan pharma may demonstrate that a cheaper manufacturing base is not necessarily the solution to our problems.
Post Date: 08/02/2011
Author: Ali Afnan, Principal, Step Change Pharma, Inc.

FDA Fields Tough Questions About Inspections, Challenges Pharma to Be Open, Honest

Last month in Bethesda, at a conference on the Current Challenges of GMPs, presented by Pharma Conference, Inc., FDA officials took FDA’s transparency mandate to new levels, by discussing some of the issues they are seeing at pharmaceutical manufacturing and quality operations.
Post Date: 07/26/2011
Author: Agnes Shanley, Editor in Chief

PharmaView: Shattered Trust in Manufacturing and FDA, a Renewed Faith in the Press

A Milwaukee newspaper reminds an industry of its flaws.
Post Date: 07/12/2011
Author: Paul Thomas, Senior Editor

From the Editor: Is the “Desired State” Really Desired?

Research suggests that a dysfunctional relationship between regulator and regulated is delaying pharma’s progress.
Post Date: 05/10/2011
Author: Agnes Shanley, Editor in Chief

Pfizer Reinvents Lean in the Lab

At the core of missed opportunities in pharma QC/QA is a subtle misunderstanding of the real intent of Lean.
Post Date: 05/04/2011
Author: Lorcan Mannion, Operations Practice Manager, BSM Ireland, and Ciarán Crosbie,...

Meeting the Supply Management Challenge

To manage increasingly complex supplier networks, pharmaceutical companies must develop new capabilities, organizational structures and management tools.
Post Date: 05/04/2011
Author: Ric Philips and Kevin Sachs, McKinsey & Co.

Can You See the Real QbD?

Rather than helping, could the current brand of pharmaceutical Quality by Design be acting as a distraction and deterrent to quality?
Post Date: 05/03/2011
Author: Gawayne Mahboubian-Jones, Program Manager for Excellence in Science and ...

Moving Beyond the Business Case for QbD
The case has already been made that Quality by Design can make drug manufacturing both faster and cheaper. But success depends as much on organizational issues as technical ones, write Ted Fuhr and Katy George of McKinsey & Co.
Post Date: 04/18/2011
Author:

Winning the cGMP Whistleblower Game

Respond fully to allegations, experts say; if you’re considering blowing the whistle, be sure the noncompliance is serious enough to threaten product integrity.
Post Date: 03/16/2011
Author: Agnes Shanley, Editor in Chief

Vital Links: Supplier Risk Monitoring

Organizations which adopt and implement a comprehensive supplier risk monitoring program will have visibility into a broad spectrum of overall supplier risk factors, not just compliance.
Post Date: 03/15/2011
Author: Scott Chizzo, President & Chief Consultant, Maxiom Group, Frank Gaibor, ...