Course Description:
USP General Chapter <905> Uniformity of Dosage Units is internationally harmonized and has been official since USP 34–NF 29 (2011). A “Test by Values” approach is used in this harmonized chapter to assess the uniformity of dosage units. This webinar will explain, through various case studies, the calculation of the Acceptance Value, which is a critical step of the “Test by Values” approach—this webinar will also discuss the application of USP General Chapter <905> to various dosage forms.
Upon completion of this course, you will:
- Explain the rationale of the current harmonized compendial approach to the problem of uniformity of dosage units
- Calculate the Acceptance Value in determining conformance with the acceptance criteria
- Describe and use the concepts of the Acceptance Value, L1 and L2, Target Value, Reference Value, and Acceptability Constant
- Apply USP–NF General Chapter <905> to various types of formulations
- Determine when to use the “Weight Variation Test” and when to use the “Content Uniformity Test”
- Understand how to extend USP <905> to large sample sizes.
- Determine a batch release strategy to ensure compliance with USP <905>
Who should participate:
- Analytical chemists
- QC managers
- QA managers
- Compliance managers
- Lab managers
- Production managers
- Regulatory
- R&D
The live version of this recording took place on June 15, 2022
There will be a knowledge assessment at the end of the course. If this course is taken as part of the USP certificate program, you will be required to pass this knowledge assessment with a score of 80 percent to determine if your comprehension of the topics presented meets USP’s minimum requirements.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Steven Walfish
USP Senior Principal Scientist
B.A., statistics, University of Buffalo
M.S., statistics, Rutgers UniversityMBA, Boston University