Attendees: * denotes chair
Academia/Industry Representatives:
Sylvia Gantt, PQRI Executive Secretary
Sidney Goldstein, D.Sc.-Duramed - GPhA
Richard C. Moreton, Ph.D.-Penwest - IPEC
David Pang, Ph.D.-AAPS
Richard P. Poska, R.Ph.-Abbott - ISPE
Shawn F. Dressman, Ph.D.-USP (by telephone)
FDA Representatives:
Rajendra Uppoor, R.Ph.
Devinder W. Gill, Ph.D. (by telephone)
Observers:
Thomas Garcia, Ph.D.-Pfizer-BUWG (by telephone)
Approval of Minutes
The minutes of the January 16, 2001 meeting were approved without modification.
Summary of the February 6 Steering Committee Minutes
The issue of intellectural property will be addressed by the Policy Committee. The request for a research plan and proposed budget from the BUWG will be submitted following the submission of the final draft of the stratified sampling proposal
A PQRI meeting with Steering Committee, Technical Committees and Working Groups will be scheduled later this year.
Concerns of DPTC -
Tom Garcia informed Sid Goldstein that Bill Paulson had called him to clarify the article prior to publishing the coverage of the Blend Uniformity Workshop in the Gold Sheet.Blend Uniformity Working Group Status - A draft of the survey results has been circulated to the DPTC. PQRI BUWG's "Updated 02/02/2001" version of the stratified sampling proposal to demonstrate blend uniformity of powder blend was reviewed by the DPTC.
Raj Uppoor and Dave Gill communicated FDA/CDER BUWG's suggestions for revising the PQRI BUWG's "Updated 02/02/2001" draft proposal of "The Use of Stratified Sampling of Dosage Units or Blend Sample Data to Demonstrate Blend Uniformity of Powder Blends (with 4 Attachments)". The suggestions made by Raj and Dave were based on discussions and recommendations of the CDER BUWG members, following their meeting of 2/13/2001.
The suggestion from CDER members was to apply the in-process BUA and in-process dosage units analysis and evaluation (Attachment 2) to ANDA biobatches also, and to eliminate upon successful commercial scale validation, the proposal to perform Routine Evaluation (Attachment 3). The suggested concepts were discussed by the DPTC in detail, along with Tom Garcia. The DPTC recommended that revisions in BUWG's "Updated 02/02/2001 draft proposal" would be appropriate. In continuation, Tom Garcia proposed to present DPTC's recommendations and CDER's suggestions to the members of the PQRI BUWG in a telecon meeting, on 2/21/2001 at 9:00 am. Rich Poska (tentatively) and Raj Uppoor planned on joining the telecon meeting.
Manufacturing Changes Working Group Status - Ajaz Hussain and Colin Gardner agreed to write a research proposal for this working group. This proposal will specify the scientific expertise needed for this working group.
Container/Closure Systems Working Group Status - Don Klein agreed to recommend FDA representatives to this committee.
Miscellaneous Items
The DPTC agreed that the process for approving candidates to the working groups would be for the DPTC to appoint members based on their scientific expertise. This list would be submitted to the Steering Committee for final approval.
Next Scheduled Meeting
The next scheduled meeting of the DPTC has been set for 10AM March 13 at the AAPS headquarters in Arlington, VA