Zachary Brennan of in-PharmaTechnologist.com shares that both the U.S. Pharmacopeia (USP) and the ICH are currently updating elemental impurity standards and there are some differences between the two. This could cause costly reformations in the future for companies that must meet these guidelines. Other organizations such as the EU or the Japanese Pharmacopeia declared that they would wait for the ICH to finish before they developed their own standards. David Schoneker, chairman of the Coalition for the Rational Implementation of USP Elemental Impurity Requirements, whom found the situation puzzling, added “There isn’t an imminent safety problem. We want better controls on metals, and we just want better ideas that don’t create waste.” Why do you think the USP went against reasonable time standards to develop impurity standards? Read the full article here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
Life Science Accelerated
Our experts are dedicated to expediting life science product development regulatory pathways.