Pharmaceutical and Biopharmaceutical Manufacturing

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Featured Content

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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Changing Pharma’s Negative ...

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

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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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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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Understanding Pharma Patents

Pharma's patent cliff is redefining the industry. Here, ...

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Question-Based Review, APIs & the ...

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

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The Pharmaceutical Industry: ...

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

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The Generic Drug Market

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

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Pharma Evolution Blogs

A Spoonful of Sugar

Adele Graham-King, Blogger, 17/05/13 Comment now

When I was young, we were given our polio vaccine on a sugar cube. We were given medicines full of sugar, we held our noses to take nasty suspensions, and we were regularly pinned down by our parents to ensure that we took the horrid ...

Latest comment @s1234macdougall I agree that the pharmacist should be responsible for tailored individual dispensing and can give assistance in...

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 sure hope this venture is sucessful. Needy patients miss opportunities to participate in clinical trials that may save their lives....

PharmaEvolution Case Files 4

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

Who is advancing a smarter approach to pharma, and who isn't? Here's a look at those who have spurred positive change, and those who haven't.

Latest comment I think Dinesh received a justified reward for doing good. There are not enough examples of reward for good behavior in this world...

Are You Smarter Than an FDA, EMEA, or PIC/S Inspector?

Barry A. Friedman, PhD, Independent Consultant, 15/05/13 Comment now

No offense intended to the diligent and well-educated staff of the FDA and other global regulatory bodies, but, as our previous blog post suggests, there may be less precision than there should be in written facility observations. ...

Latest comment I wonder how an inspector would score on this cGMP test.

Are Regulators Missing Opportunities for Greater Clarity on Aseptic Requirements?

Barry A. Friedman, PhD, Independent Consultant, 14/05/13 Comment now

Ever wonder how FDA's Office of Regulatory Affairs (ORA) selects the most appropriate plant observations? Each year FDA's CDER summarizes the number of significant observations obtained from Form FDA 483s. The observations cited within ...

Latest comment I think it is a scary thought that our trusted FDA regulators are missing opportunities to clarify their regulatory language on aseptic...

Improving APIs & Formulation: Are You Harnessing the Power of Liquids?

Girish Malhotra, President & Founder, Epcot International, 14/05/13 Comment now

Liquids are an essential part of our planet. Imagine our landscape and lives without them. We may take them for granted, but liquids play an important role in the reactive processes that produce small molecule active pharmaceutical ...

Latest comment This is a good review of basic solvent chemistry. I wonder how many industry professsionals are, in fact. "harnessing the power of...

More Blogs

Biosafety Cabinets & Laminar Flow Hoods Are Not Interchangeable

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Where Did the Term 'Design Space' Come From Anyway?

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Outliers: Taking the Road Less Traveled

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Who Has Won Our Cartoon Caption Writing Contests So Far?

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Slideshow: How to Get in Trouble With [INSERT REGULATORY AUTHORITY HERE]

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