Articles

• PharmaView: Shattered Trust in Manufacturing and FDA, a Renewed Faith in the Press

  A Milwaukee newspaper reminds an industry of its flaws.

• Chatterjee: How Much is Enough? API Quality Assurance and the New Process Validation Guidance

  The challenge all quality professionals face is answering the question, “How much is enough?”

• Therapeutic Dose: Facilius per Partes in Cognitionem Totius Adducimur

  We are more easily led part by part to an understanding of the whole. –Seneca

• Exploring Fluorescence as an Online PAT Solution

  Mike Ponstingl, owner of Custom Sensors & Technology, shares insight into new methods of monitoring fermentation and other bioprocesses.

• From the Editor: Channeling General Patton

  Pharma could learn a few lessons in accountability and respect.

• Afnan's Letter from Japan: Japanese Pharma's Embracing PAT, QbD and Opex Tools

  As its auto industry has done, Japan pharma may demonstrate that a cheaper manufacturing base is not necessarily the solution to our problems.

• Shoring Up Pharma’s Middle Management

  Organizations with built-in risk management frameworks allow middle managers to thrive, says Scott Chizzo, Maxiom Group’s president and chief consultant, in this exclusive interview.

• Tales from the Middle

  Pharma's middle managers carry on despite a "damned if we do, damned if we don't" environment.

• The Good Fight: The Plight of Pharma's Middle Managers

  Middle managers in pharma today have a tough, thankless job—but someone’s got to do it, and many do it well.

• Life Science Level Measurement: An Update

  What was once a laborious process is getting easier, thanks to modern sensors and calibration procedures.

• Sorry, Agnes. Pharmaceutical Pricing Does Follow the Laws of Supply and Demand

  Reader response from last month's Editor's letter.

• The Need for New Models in Identifying New Molecules

  Probabilistic rather than deterministic modeling is essential, says Quintiles’ Davis Walp.

• Digital Insights: Pharma Tears Down Facebook Wall

  Facebook is going back on its pledge for full transparency and giving pharma companies the option to turn off their wall feature if pages meet specific criteria, thus hindering users from commenting publicly.

• Computer System Validation: Eight Challenges on the Way to the Target State

  IT compliance today requires a paradigm shift from a project-specific engagement to a comprehensive, centralized compliance program.