Attendees: *denotes Chair
Academia/Industry Representatives:
*Sid Goldstein, D.Sc. - Duramed/GPhA-Chairman
Sylvia Gantt, PQRI Executive Secretary
Richard P. Poska, R.Ph. - Abbott/ISPE
Shawn F. Dressman, Ph.D. - USP
FDA Representatives:
Ajaz Hussain, Ph.D. - CDER/OTR
Devinder W. Gill, Ph.D. - CDER/OGD (by telephone)
Rajendra Uppoor, R.Ph. - CDER/ONDC
Observers:
Thomas Garcia, Ph.D. - Pfizer/BUWG
Jerome A. Planchard, Ph.D. -Aventis/BUWG
Absentees:
Larry Augsburger, Ph.D. - AAPS
Colin Gardner, Ph.D. - Merck/PhRMA
Nikki Mehringer, Lilly/PDA
Richard C. Moreton, Ph.D. - Penwest/IPEC
Approval of Minutes
The minutes of the February 20, 2001 meeting were approved.
BUWG Status
1) The final draft of the stratified sampling proposal will be available for
review by the DPTC before their April 17 meeting.
2) The final draft or the report on the industry blend uniformity practices survey will be reviewed by the DPTC and submitted to the PQRI Steering Committee for their approval to publish.
3) Jeff Guentensberger (Geneva) and Michael Bogda (Barr) have been approved as candidates by the BUWG. Tom Garcia will contact them to determine if they have the time to commit to this committee.
Container/Closure Systems Working Group Status
Chris Moreton is in the process of finding candidates for this working
group.
Manufacturing Changes Working Group Status
A research proposal will be submitted by Ajaz to the DPTC prior to the April
17 meeting. The proposal will be based on a short term project that will
focus on SUPAC level 3 changes. This will involve developing a rational
approach to reduce level 3 changes to level 2 or 1 by focusing mainly on
changes and their effect on stability(shelf life). The long term approach
will involve new technology for monitoring manufacturing processes based on
studying unit operations.
Miscellaneous Items
1) Ajaz reported on the New Technology Forum that took place in the UK last
month.
2) Colin Gardner has decided to take early retirement from Merck and has resigned from PQRI. The DPTC is requesting the Steering Committee to nominate someone to represent PhRMA on DPTC.