Quality Disconnect - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Quality Disconnect
QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.

Pharmaceutical Technology
Volume 32, Issue 1

Angie Drakulich
Welcome to Pharmaceutical Technology's new PharmTech Talk column. In the year ahead, our editors will be discussing what we hear you discussing such as the statement above. We all attend conferences and workshops, and we all sit quietly and nod our heads as we listen to experts and regulators tell us what we're supposed to be doing to meet standards. But during much-needed coffee breaks, predinner cocktails, and networking receptions, real views tend to come out. It's in those "off-the-record" chats that we hear what you really think about "the state of the industry."

Take the 2007 American Association of Pharmaceutical Scientists meeting. Despite the numerous, jam-packed quality-by-design and process analytical technology sesssions, I kept hearing disgruntlement from attendees: "Why do we have to change our entire system if FDA is not changing the way it does inspections?" "If we provide FDA with more detailed information, that will open the door to more questions—and perhaps less approvals." "I agree with QbD, but the higher-ups won't pay for it until there are proven results (i.e., revenue)." "Quality systems and harmonization are not required—so why follow them?"

Another common concern had to do with the global impact on the pharma industry. If a company finalizes its design space, for example, and then decides to contract out a few steps, different regulations in different countries throw a wrench in the whole based, risk managment" plan.

We'd like to hear your thoughts on these issues, so please email
Stay tuned for more PharmTech Talks. Angie Drakulich is the managing editor of Pharmaceutical Technology.

A few readers commented on this column. Click here to read their thoughts.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here