July/August 2006 Issue

Articles

  • Waxman Thrusts, FDA Parries, No One Wins

    A June 26 report issued by Rep. Henry Waxman took FDA to task for what it cited as a dramatic decline in enforcement activity during the past five years. The Agency's reply was official yet defensive.

  • Silencing the cGMP Priesthood

    cGMPS are essential, but when cGMP dogma triumphs over common sense and prevents innovation, we’re all in trouble, says NIR expert and pharmaceutical industry consultant Emil Ciurczak. He offers some tips for drawing the line between compliance and absurdity.

  • CAPA and Root Cause Analysis

    Recent FDA Warning Letters have cited insufficient corrective and preventive action (CAPA) programs as major compliance weaknesses. How does one ensure one’s CAPA is on the right track? Doug Bartholomew interviews industry QA professionals and leading consultants for the answers.

  • PAT in Perspective: Drugs Are Not Potato Chips

    Although PAT and technologies like NIR are important, there still are things that they cannot do, concedes NIR expert Emil Ciurczak. Are advocates within the industry suspending rational and much needed skepticism, he asks, when they talk about eliminating final product stability testing altogether?