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Single-Use Equipment ...

It's the users in biopharma who will benefit from ...

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No Nonsense Computer Systems ...

ISPE's GAMP is a useful guide, but may not be practical ...

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Product Volume & API Process ...

API manufacturing processes can be complex and ...

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FDA Crackdown on Compounders: Too ...

The FDA now admits that it could have done more to ...

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Changing Pharma’s Negative ...

Former Pfizer R&D chief John Lamattina proposes some ...

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Slideshow: How to Get in Trouble ...

The FDA's CDER recently summarized the top 15 inspection ...

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Where Did the Term 'Design ...

A look at the origins of a much debated and contested ...

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ICH Q11 & Stealth QbD for Drug ...

Last May, ICH Q11 came on the scene without much hoopla, ...

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What's in Your Risk Policy?

Pharma is finally moving away from a check-the-box ...

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How Well Do You Understand ...

The right approach to supply-chain management involves ...

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Quality & Risk Management: Beware ...

Never underestimate the complexity of pharmaceutical ...

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So You Think You Know Lean?

Do you understand Toyota Production System concepts and ...

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Pharma Evolution Blogs

QbD on the Menu at CPhI Mumbai: Industry Savings of $200 Billion Possible

Agnes Shanley, Editor-in-Chief, 19/06/13 Comment now

The air was full of three-letter acronyms at CPhI's recent conference on process analytical technology (PAT) and quality by design (QbD) in Mumbai. QbD even found its way to the dessert trays.

Latest comment It is frustrating when data is presented, showing the millions that could be realized from QbD, and the response is "so?" As long...

Can Industry Help Transform Pharmaceutical Education & NIPTE?

Agnes Shanley, Editor-in-Chief, 18/06/13 Comment now

Prabir Basu, who has led the National Institute for Pharmaceutical Technology and Education (NIPTE) since it was founded in 2005, is leaving the organization at the end of this month to pursue other research opportunities, and to ...

Latest comment I believe in science education and that there is definitely more of a need for pharmaceutical education. NIPTE sounds like a great...

Career Networking (Fake It Until You Make It)

Agnes Shanley, Editor-in-Chief, 17/06/13 Comment now

Have you ever watched a brilliant and creative expert muff an opportunity to impress a top executive? It's not a pretty picture, and it happens every day and in every profession.

Latest comment Back in the mid-1980s, in the midst of a rapidly expanding QC department (millions of dollars, in fact), I was tasked with evaluating,...

Can Packaging Design Stop the Accidental Overdose?

Adele Graham-King, Blogger, 14/06/13 Comment now

I recently blogged on the potential cardiac risks associated with the long-term use of high doses of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), specifically ibuprofen and diclofenac.

Latest comment @ALM I suspect you are completely correct. Generic presentation, cheaper packaging, lower production cost and as basic as is possible....

Overcoming Bioavailability Challenges: The Event (& the Crib Sheet)

Agnes Shanley, Editor-in-Chief, 14/06/13 Comment now

On Wednesday, June 12, the Catalent Applied Drug Delivery Institute, established last year to offer training and resources on drug development, delivery, and formulation, held its first live event, "Overcoming Bioavailability ...

Latest comment Interesting program! I wonder if they would offer members of the media a free pass to cover the individual lectures or whole progr...

This Week's Cartoon Caption Writing Contest Winner Is...

Agnes Shanley, Editor-in-Chief, 13/06/13 Comment now

...Blogger Emil Ciurczak, who gets extra points for his knowledge of art. (Emil likes to paint himself, and is also an excellent ballroom dancer, by the way.) Congratulations, Emil.

Latest comment i just became a fan of Escher. Great job, Emil!

More Blogs

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Are You Processing Particles or Powders?

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Most Commented

Changing Pharma’s Negative Public Image

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NSAIDs: What Do We Do With the Additional Risk Information?

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Thriving, Not Just Surviving, in a World of Constant Change

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Pharmaceutical Quality: Our Platform's Not Burning, It's Leaking!

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Will US Senate Track & Trace Proposal Really Protect the Supply Chain?

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Diabetes Vaccine: Great Leap Forward or Bag of Empty Promises?

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Blogs Archive

Video Blogs

Russ Somma on QbD

It's a business method, not a filing strategy, and ...

2 comments

Rajesh Nair: Future Pharma to ...

Instead of looking inward, forward-thinking companies ...

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Using New Process Validation ...

Wai Wong, VP and GM of global operations at Pharmatech ...

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Playing Catchup: Protecting ...

Consider information, not just product, and work with ...

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Why Biogen Idec Won the 2013 ...

Why Biogen Idec's Flexible Volume Manufacturing Facility ...

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IPS's John Gilroy on Modular ...

During his Interphex show floor tour, he discussed ...

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Jacobs GVP Bob Pragada on the ...

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California's e-Pedigree ...

John DiPalo, COO of Acsis, discusses the impact ...

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Aseptic Equipment Trends

IPS's Jason Collins on key trends, such as reducing ...

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Russ Somma on Tableting & ...

Sommatech consultant Russ Somma discussed trends in ...

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A Look at Interphex 2013

Highlights from the pharma exposition and conference ...

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On the Floor at Interphex 2013: ...

We follow biopharm tour guide Chuck Stock and view some ...

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Video Archive

Message Boards

netterjr 6/19/2013 6:09:10 PM
NSAIDs: What Do We Do With the Additional Risk Information?
Re:overuse:
Thank you for replying to my comment. You make some valid points as well. Let's agree to disagree, Adele. :)

Emil W. Ciurczak 6/19/2013 5:48:18 PM
QbD on the Menu at CPhI Mumbai: Industry Savings of $200 Billion Possible
CPhI Mumbai:
It is frustrating when data is presented, showing the millions that could be realized from QbD, and the response is "so?" As long as HMOs and governments pay the price of poor quality, there is NO incentive to improve. We (all countries and bill-payers) need to squeeze the industry...

Adele Graham-King 6/19/2013 5:47:25 PM
NSAIDs: What Do We Do With the Additional Risk Information?
Re: Overuse:
James, Ads maybe good for certain populations but not all. The elderly for example may not watch TV or read magazines, but a blazing red 'Eat one of me!' On the back of a tablet packet might stand out? I feel that general media in such circumstances may just miss a few important...

Emil W. Ciurczak 6/19/2013 5:37:09 PM
Russ Somma on QbD
Russ Somma:
I mostly agree with Russ. However, I would like to know what he meant by "getting hung up on PAT." Since no matter how much information you have on developing a product, if it is not monitored and controlled during production, making a product without monitors is, as Ali Afnan said,...

netterjr 6/19/2013 5:22:57 PM
QbD & Getting Off Buridan's Ass
Re: proceedings:
Thank you for letting me know. That is too bad.

netterjr 6/19/2013 5:21:16 PM
NSAIDs: What Do We Do With the Additional Risk Information?
Re: Overuse:
Thanks for replyying to my comment, Adele. I think that magazine ads or TV ads would be a more effective way to convey info about the drug.

Adele Graham-King 6/19/2013 4:48:23 PM
NSAIDs: What Do We Do With the Additional Risk Information?
Re: Overuse:
James I agree with you in as much as there is limited education with regards to dangers of most OTC drugs and their dosing. The drugs sre definitely overused... but that's probably due to the former. However if there is no additional information in the packaging (if you can find...

Agnes Shanley 6/19/2013 3:57:29 PM
Russ Somma on QbD
QbD and Supplier Management, Another Viewpoint:
...and for another point of view, check out this blog post from BioProcess International, written by Tunnell consultant Paul Catania.

Agnes Shanley 6/19/2013 3:51:19 PM
QbD on the Menu at CPhI Mumbai: Industry Savings of $200 Billion Possible
More on QbD From Russ Somma:
Just posted a video blog by someone who knows his way around the design space and QbD: Russ Somma. Knowledge management is critical, he says, as is the knowledge that it's a business method, not some magic bullet required by regulators.

Jack Carroll 6/19/2013 2:52:08 PM
QbD & Getting Off Buridan's Ass
Re: Proceedings:
I'm sorry to say that there will be no published conference notes. The conference itself was privately sponsored by a single pharmaceutical manufacturer with multiple -- and multinational-- locations. The sponsoring company has an overall interest in QbD efforts. The conferees...

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