USP General Chapter <467> Post July 1st 2008 – What Now?

On July 1st, 2008 the requirements to the United States Pharmacopeia (USP) general chapter <467> for the identification and control of residual solvents became official. Although the USP and FDA have held many educational events to help companies understand the scope of these new standards, there is still significant confusion. On August 8th the FDA published a draft guidance for industry entitled Residual Solvents in Drug products Marketed in the United States. This guidance is intended to help companies understand their testing requirements and the documentation that needs to be provided in order to demonstrate compliance with the new standards. For the past two years, Phenomenex, in cooperation with the USP, has been presenting one and two day hands-on training courses to help people prepare for the upcoming changes. In this article, we will review the topics covered in the FDA guidance and help to address other common questions that we have received during our educational sessions.

The first thing for manufacturers to understand is that this new guidance applies to all compendial human and veterinary drug products, including those already being marketed and sold through an approved New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA).1 This is different to how this standard was originally approved by ICH. When the ICH Q3C guideline was first issued it pertained only to newly marketed

drugs. It wasn’t until the standard was adopted by EP that it was applied to drug products currently on the market. This difference in scope was one of the main reasons for the delayed adoption of the Q3C guideline by USP.2