As many of you are aware, USP General Chapters <232>/<233> will take effect January 1, 2018. These pertain to Elemental Impurities in all drug products, and many of our previous blogs, videos and website content have been dedicated to this topic, given the importance of compliance.
Over the course of this year, we’ve worked with many Pharma clients and Excipient manufacturers to assist them with the transition to the new guidelines. As much as we may assist in the process, it is ultimately the responsibility of the client to determine the appropriate steps for compliance, including performing Risk Assessments, Validations and/or Verifications of methods for testing individual products, and Release Testing.
As companies navigate this somewhat-complex route to compliance, we’ve often referred them to the ICH Q3D Training Modules. These modules contain guidance for understanding the USP Permitted Daily Exposures for Drug Products (included within USP<232>), performing reasonable Risk Assessments for their Drug Products and/or Excipients, and the testing methods as per USP<233>. They also provide case studies which pull together the pertinent information into straight-forward, practical illustrations for the manufacturer.
We’ve found these so useful for our end customers, that we’ve included them within the ‘Resources’ section of our web site, which you can access at by clicking here.
As always, should you have any questions with respect to USP<232><233> and/or the ICH Q3D guidelines/training modules, please feel free to contact us anytime at email@example.com, or by calling 717.697.7536.