As referenced in previous blogs, and on the minds of many of our clients, is the topic of Elemental Impurities and compliance with the U SP <232/233> requirements and recently the FDA released information that can be incredibly helpful for submission of Elemental Impurities data.
Given that the USP <232/233> General Chapters became official on January 1st, many companies are working to ensure that their risk assessments, drug product screenings and method validations are in place in a timely manner. While developing a Risk Assessment strategy is the first step in the process, subsequent screenings and method validations are key in completing the process for compliance with USP <232/233>. CSL has been working with several drug manufacturers to develop screening and validation strategies, protocols and schedules. In doing so, clients have been able to present a clear, concise plan for coming into compliance with the USP <232/233> requirements.
On February 7th, the FDA posted a document which we thought would be helpful to our pharma clients, as they consider timing of submission of their Elemental Impurity information. This posting, entitled ‘Considerations for applicants deciding when to submit elemental impurity data to FDA’ can be found here.
We hope this is helpful information and, as always, welcome your calls/emails/discussions regarding implementation of Risk Assessment strategies. Contact us today for guidance!