Objectives of the Presentation
Upon completion of this course the participants will be able to:
Why Should you Attend
- Understand the requirements for residual solvents addressed in ICH, USP, EP and JP
- Take advantage of the flexibility introduced in the revisions to USP <467>
- Utilize strategies to minimize the testing and resources required to meet the requirements
- Verify the USP procedure (or validate alternatives) in accordance with expectations
This webinar will focus on recent changes to USP <467> which can increase flexibility and reduce workload for testing of residual solvents in raw materials and finished products. We address options such as whether to test raw materials or drug products, whether to use USP or alternate testing methods, when to screen for all solvents and when to test for specific solvents. Significant resources can be saved by reduced testing, and we discuss the steps necessary to do this successfully.
We’ll explain how new information on verification or validation of analytical procedures clarifies what must be done. We also talk about some of the unresolved challenges related to residual solvents compliance.
Who will Benefit
- Regulatory Landscape for Residual Solvents: ICH, USP, EP and JP
- Revision to USP <467>: improved clarity and flexibility
- Discussion on various approaches to compliance, and how to minimize resources
- Unresolved issues: solvents with poor volatility not yet addressed
- Questions and Discussion
This webinar will provide valuable assistance to all drug companies/ manufacturing sites. Those that would benefit most would be:
- Chemists (Research, Quality Control, CRO) involved with residual solvents testing and their managers
- Regulatory affairs/CMC personnel responsible for documenting compliance with residual solvents requirements
- Laboratory managers and staff
- QA/QCU managers and personnel
- Training department
- Documentation department
Compliance with compendial standards for residual solvents is required for all drug products provided in the United States, and similar requirements exist in all the major markets of the world. Since every product is unique, and since the requirements refer to over 50 different solvents, achieving compliance can be very challenging. Many, many firms have received incomplete or warning letters from the FDA as a result of failure to adequately address the reporting of residual solvents.