USP Update: New USP PVT Subcommittee and Archived Webinar

USP PVT Subcommittee

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:

• Vivian Gray, subcommittee chair
• Ralph Heasley
• Johannes Krämer
• Alan Parr
• Galen Radebaugh
• Thomas Tice
• Tahseen Mirza, FDA liaison

Will Brown serves as subcommittee liaison.You can contact the subcommittee through Will's e-mail address, web@usp.org.

USP Webinar, Performance Verification Program (Prednisone Tablets)

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:

1. How does USP assign PVT acceptance limits for Prednisone tablets?
2. Why did USP take the new approach to the form of the acceptance criteria?
3. Why does USP not consider mechanical calibration sufficient to demonstrate proper performance of the dissolution assembly?
4. What is the inherent tablet-to-tablet variability?
5. Does USP have instructions for weighing or de-dusting tablets?
6. Should tablets not be used based on physical condition?
7. The dissolution apparatus that we use had passed PVT with Lot P0 but is now failing with Lot P1. We need to assess the impact to the products we released between these two PVTs. Would USP provide us a justification?
8. We noticed P1 tablets float when tested by Apparatus 1, which gave higher results. What should we do?
9. What if a tablet does not drop into the center? Does USP have dropping instructions?
10. Why does the USP toolkit differ from <711> Dissolution?
11. What does USP consider an appropriate deaeration procedure?
12. What do I do when the PVT fails?

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.