Course Description:
Significant revisions to standards for residual solvents found in USP─NF General Chapter <467> Residual Solvents became official on March 1, 2019. At the same time the companion USP chapter <1467> Residual Solvents-Verification of Compendial Procedures and Validation of Alternative Procedures became official. Additional revisions were made to USP <467> and became official on December 1, 2020 to align with ICH Q3C(R6) which reclassified methylisobutylketone from a Class 3 to a Class 2 residual solvent and added triethylamine as a new Class 3 residual solvent. Other related topics will be discussed including validation and verification of residual solvent testing as outlined in USP <1467>.
The live version of this recording took place on June 2021. Video includes English subtitles.
Upon completion of this course, you will be able to:
- Understand the historical approaches and standards contained in USP General Chapter <467>.
- Apply a risk-based strategy concept for complying with residual solvents content in pharmaceutical requirements of USP <467>.
- Illustrate Options 1 and 2, as well as Procedures A, B, and C as described in USP <467>.
- Differentiate between validation and verification and understand when to use alternative procedures.
- Understand validation and verification requirements as described in USP General Chapter <1467>.
Who should participate:
- QC/QA
- Compliance staff
- Laboratory scientists
- Managers in the pharmaceutical and allied industries
- Regulatory professionals
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.