USP and ICH butting heads on elemental impurity standards

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.

EMA Attempts To Support Continuous Process Verification With New Guidelines

The European Medicines Agency (EMA) has released draft guidelines regarding continuous process verification (CPV) to bring its policies in line with ICH Q8, Q9, and Q10.  The goal is to gain information a manufacturer can use to make adjustments during production to maintain drug quality, “If appropriate, the product may benefit from a defined period of enhanced sampling and monitoring to help increase process understanding as part of continuous improvement,” the EMA wrote.  While the EMA has acknowledged the benefits CPV can provide, it also says a hybrid approach using traditional process validation is also an option.  To read more, click here.  To view the EMA’s draft guideline, click here.