A new subcommittee has been formed to advise on the USP performance verification test program. The subcommittee reports to the General Chapters Dosage Forms Expert Committee (GCDF) chaired by Jim De Muth, Ph.D. The subcommittee will review USP efforts to provide standard materials, procedures, and criteria relating to the performance qualification of dosage form performance test equipment.
Subcommittee members are:
Will Brown serves as subcommittee liaison.You can contact the subcommittee through Will's e-mail address, web@usp.org.
USP has produced an on-demand, recorded webinar to answer commonly asked questions regarding the performance verification test (PVT) using USP reference material Prednisone Tablets RS . The webinar as released for viewing in November 2010 and is available at the USP website, http://www.usp.org/education/pe/courses.html. The content for the webinar was drawn from questions received by USP staff about the new procedure and criteria for the PVT that came into effect with the release of USP Prednisone Tablets RS, Lot P1I300 (Lot P1). Key USP staff members served as the faculty for this online course.
Questions that were addressed in the hour-long webinar were:
The staff presenters were:
Walter Hauck, Ph. D., Senior Scientific Fellow, who as staff statistician has worked on the design of the P1 collaborative study and was responsible for the data analysis that determined the acceptance limits.
Erika Stippler, Ph. D., Director of the Dosage Forms Performance Laboratory (DFPL), who worked on the design and execution of the P1 collaborative study. Among other tasks, the DFPL conducts the stability studies on all USP PVT reference standards.
Chensheng ( Trish) Li, Ph.D., Reference Standard Scientist V, who as a member of the Reference Standards Evaluation Department has the prednisone tablet in her portfolio of reference standard materials and worked on the organization, design, data coordination, and analysis of the collaborative study.
Will Brown, Senior Scientific Liaison, who as a member of the General Chapters Department is responsible for the maintenance and revision of the dissolution general chapter. Will worked on the design and evaluation of the collaborative study and played a key role in the development of the dissolution toolkit.
Questions regarding the USP PVT or USP Prednisone Tablets RS should be directed to AskUSP@usp.org.