Pharmaceutical and Biopharmaceutical Quality

PHARMA EVOLUTION MOBILE
CPhI WORLD MOBILE

Featured Content

Single-Use Equipment ...

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

8 comments

No Nonsense Computer Systems ...

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

7 comments

Product Volume & API Process ...

API manufacturing processes can be complex and ...

8 comments

FDA Crackdown on Compounders: Too ...

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

12 comments

Changing Pharma’s Negative ...

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

29 comments

ICH Q11 & Stealth QbD for Drug ...

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

6 comments

What's in Your Risk Policy?

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

8 comments

Quality & Risk Management: Beware ...

Never underestimate the complexity of pharmaceutical ...

8 comments

So You Think You Know Lean?

Do you understand Toyota Production System concepts and ...

6 comments

Question-Based Review, APIs & the ...

Question-Based Review could be a way to help ensure the ...

6 comments

The Pharmaceutical Industry: ...

The patent cliff, healthcare reform, growth of the ...

6 comments

The Generic Drug Market

Here's a quick visual summary of the generic drug market ...

0 comments

Pharma Evolution Blogs

Digital Adrenaline: Can An App Be Effective in Drug Delivery Training?

Adele Graham-King, Blogger, 22/05/13 Comment now

While considering packaging issues related to emergency drug delivery devices, I recently came across a new app that simulates adrenaline delivery.

Latest comment This is true - on both points. And I think that if even one life can be saved because someone 'had seen it somewhere before' it must...

Electronic Batch Records: Are Your Systems Ready for Inspection?

Jim Cahill, Head of Social Media, Emerson Process Management, 21/05/13 Comment now

Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers. From a computerized system standpoint, the rules of Part 11 (Electronic Records; Electronic Signatures - Scope and Application) and ...

Latest comment I find it ironic that computers seem to make it more difficult to make notations in batch records than pen-and-paper. Why bother having...

In-Silico Drug Development: A Must-Read Paper

Agnes Shanley, Editor-in-Chief, 20/05/13 Comment now

And now for the second article in the brief "technology of tomorrow" series...

Latest comment I agree with the authors of this article. Six-sigma should be more stringently applied in pharma to improve quality.

Can Simulation Take Drug Development Into the Future?

Agnes Shanley, Editor-in-Chief, 20/05/13 Comment now

At a time when some drug manufacturers still stumble on relatively simple concepts such as loading the correct amount of active ingredient in their formulations (something that may result in criminal charges for J&J executives in South ...

Latest comment I can understand why biologicals would be more difficult to tablet under extreme compression and temperature condictions. How does...

Making New Drugs, Not Patients, the Guinea Pigs

Agnes Shanley, Editor-in-Chief, 16/05/13 Comment now

In traditional clinical medicine, patients are guinea pigs for new drugs. The risk of adverse -- or no -- effects is the price we pay for the potential of receiving treatment. But for those with terminal illnesses, even this risk is out ...

Latest comment I think that this could potentially provide interesting opportunities for terminally ill patients as so often they feel out of control...

PharmaEvolution Case Files 4

Agnes Shanley, Editor-in-Chief, 15/05/13 Comment now