Pharmaceutical Supply Chain Management

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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 ...

12 comments

What's in Your Risk Policy?

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

8 comments

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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Pharma Evolution Blogs

Slideshow: The Rogues Gallery of Pharmaceutical Counterfeiting

Agnes Shanley, Editor-in-Chief, 08/05/13 Comment now

In a discussion on this site on the topic of tracking and tracing, a question came up: Aren't counterfeit pharmaceuticals mainly a problem for developing nations and mainly an online problem in the US?

Latest comment The lack of information to monitor within supply chain is a challenge. Testing approaches and updating packaging to adhere to supply...

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

Ed Silverman, Blogger, Pharmalot, 03/05/13 Comment now

Thanks to the persistent shortage of prescription drugs and the ensuing spate of counterfeit medications, the US Congress is finally moving forward with plans for legislation designed to strengthen the supply chain. Not surprisingly, ...

Latest comment I think it's interesting that Pharma can't seem to move quickly enough on deciding, as a whole, how to implement a trace and track...

Product Volume & API Process Optimization: Connecting the Dots

Girish Malhotra, President & Founder, Epcot International, 02/05/13 Comment now

To the uninitiated, active pharmaceutical ingredients (APIs) look like wiggly, leafless branches, but they can treat diseases. Selected chemicals are reacted to produce the desired effect. The manufacturing processes can be complex. Our ...

Latest comment Making a switch is not mandatory. It is an opportunity. Each company has to consider it. A strong player who has made the switch could...

FDA Crackdown on Compounders: Too Little, Too Late

Ed Silverman, Blogger, Pharmalot, 25/04/13 Comment now

For months, the FDA has argued that its institutional hands were largely tied when it came to pursuing wayward compound pharmacies. Time and again, agency officials maintained that different rulings by the US Supreme Court left them ...

Latest comment Right. Without FDA approval opportunities supported by market-driven science and fueled by global megatrends will hinder growth, market...

Question-Based Review, APIs & the Importance of Being Biosimilar

Emil W. Ciurczak, Principal, DoraMaxx Consulting, 17/04/13 Comment now

For the last few years, and especially since President Obama signed the Patient Protection and Affordable Care Act into law nearly three years ago, we in the US have been hearing a lot more about biosimilars. Also known as "follow-on" ...

Latest comment I know some of the people who read this website...please, don't get them started on this path. ;-D

California's E-Pedigree Requirements Could Have Global Impact

Douglas Stockdale, International Life Science Industry Consultant, 11/04/13 Comment now

California's E-Pedigree law, unless otherwise challenged, could have global impact. The law takes effect on January 1, 2015, at which point any prescription drug sold in the state must comply. Now, California's population, over 38 ...

Latest comment The fifth largest economy in the world continues to do so much to help improve our planet. Fuel efficient cars would probably...

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And We'll Name the Baby... Apotex? Using Technology to Prevent Packaging Errors

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How Well Do You Understand Supply-Chain Management?

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