Articles

Can FDA Walk the Talk on Standards?

FDA’s Office of Product Quality needs a change agent. Ali Afnan has a suggestion.
Post Date: 01/07/2013
Author: Ali Afnan, Principal, StepChange Pharma

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

Managing Risk: GMPs Are Not Enough

Risk-based asset management offers a way to prioritize assets and reduce overall risk.
Post Date: 10/10/2012
Author: Mike Poland, CMRP, Life Cycle Engineering

Managing Risk: GMPs are not Enough

Risk-based asset management offers a way to prioritize assets and reduce overall risk
Post Date: 09/12/2012
Author: Mike Poland, CMRP, Life Cycle Engineering

Soaring Innovation, Grounded Goals

Readers recognize tools that break new ground but promise to improve efficiency
Post Date: 08/15/2012
Author: Paul Thomas, Senior Editor

FDA, Revisit Your Sampling Guidance!

Why are we so comfortable following draft guidance—FDA’s unfinished and incomplete current thinking?
Post Date: 08/01/2012
Author: Ali Afnan, Principal, StepChange Pharma

Serialization and Supply Chain Security

Regulatory compliance should be the byproduct, not the goal.
Post Date: 06/27/2012
Author: John DiPalo, Chief Technology Officer, Acsis, Inc.

Town Hall: FDA Braces for PDUFA V, Possible Loss of Biosimilars Authority

Janet Woodcock looks forward to having more cash and resources with new user fee legislation. Meanwhile, she raises concerns about the Agency’s authority over biosimilars should the Supreme Court strike down the Affordable Care Act.
Post Date: 06/20/2012
Author: Paul Thomas, Senior Editor

Regulation of Personalized Medicine: A Status Report

Expect evolution within the industry, as well as at FDA, as personalized medicine becomes the standard, rather than the exception, to biomedical innovation and product development.
Post Date: 06/12/2012
Author: Antoinette F. Konski, Partner, Foley and Lardner LLP

cGMPs and Statistics

FDA’s Rick Friedman and Karthik Iyer explain why some manufacturers need to get a better grip on GMP-related statistics.
Post Date: 06/05/2012
Author: Agnes Shanley, Editor in Chief

Today's Pharma: Big Challenges, Big Expectations

In an industry that faces great risk, change comes slowly—but it does come.
Post Date: 05/22/2012
Author: Nancy Berg, President, ISPE

From the Editor: Brush Up on Statistics (Or Face the Consequences)

Are you using statistics to support the status quo, or to get to true root cause?
Post Date: 05/09/2012
Author: Agnes Shanley, Editor in Chief

The Pulse of Pharmaceutical Manufacturing

The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism.
Post Date: 04/04/2012
Author: Agnes Shanley, Editor in Chief

Track and Trace Gains Prominence in the War Against Counterfeit Drugs

Regulation and technology lead the fight against counterfeit pharmaceuticals.
Post Date: 03/14/2012
Author: Franz Ludwig, Bosch Packaging Technology

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

The FDA Wants More Authority

FDA’s risk management programs must be funded and allowed to continue to evolve, but in a way that doesn’t hinder progress.
Post Date: 10/14/2011
Author: Yasmeen Muhammad, Senior Consultant, CIS

Process Validation Guidance: A Bad Fit for Aseptic Processing?

“Science-based” is well and good, but FDA’s guidance may create confusion.
Post Date: 09/28/2011
Author: Paul Thomas, Senior Editor

From the Editor: Knowledge Transfer and Minimizing Risk

When GMP's fail offshore, insufficient knowledge transfer is usually at the root of the problem.
Post Date: 09/27/2011
Author: Agnes Shanley, Editor in Chief

Compliance Update from CBER’s Malarkey: From Sterility Testing to Rapid Methods

CBER’s head of compliance sheds light on sterility testing, new guidance, and upgrading FDA’s own testing methods.
Post Date: 08/10/2011
Author:

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