Attendees: *denotes chair
Trade/Professional Associations Representatives:
William Bradley – CHPA
John B. Cox – AAPS
Fred Sexton – ISPE (via phone)
Edmund M. Fry – PDA
*Tobias Massa, Ph.D. – PhRMA
David C. Pang, Ph.D. – AAPS
Elizabeth Lane, Ph.D. – GPhA
Roger L. Williams, M.D. – USP
FDA Representatives:
Ajaz S. Hussain, Ph.D.
Vinod Shah, Ph.D.
Eric Sheinin, Ph.D.
Helen N. Winkle
Observers:
Steve Byrn – Purdue University/DSTC
Welcome and Opening Remarks
Tobias Massa welcomed the Steering Committee (SC) to the meeting.
Minutes of the SC Meeting 5/4/00
The SC approved the minutes of the 8/3/00 SC meeting with modifications.
Status of New Executive Secretary
Jack Cox reported that the search for the Executive Secretary was being
vigorously pursued, but no one had been identified. Helen Winkle offered to
provide secretary support when needed.
PQRI Operating Principles
A draft of the PQRI Operating Principles had been generated. Following correction
of minor details, the draft will be sent to Helen Winkle, Fred Sexton, Alice
Till and Jack Cox for comments.
IPAC/PQRI Collaboration
IPAC petitioned to join PQRI. The organization would like to investigate
projects regarding CMC-related problems of aerosols, e.g., plume geometry, etc.,
under the auspices of PQRI. Working groups have already been formed. IPAC is
willing to fund the projects.
The motion of incorporation of IPAC working groups into PQRI at the working group level under the joint directions of the Drug Substance and Drug Product Technical Committees (TCs) was approved by the SC. FDA will meet with IPAC on November 20, 2000 to discuss details of the projects.
Blend Uniformity Working Group
The Blend Uniformity Workshop was held on September 7-8, 2000. 173 regular
and 20 government paid registrants attended with 16 speakers participating in
the proceedings. PQRI received a net income from the workshop. In general, the
report from the participants of the Blend Uniformity Workshop indicated that
blend uniformity might not be an issue. Content uniformity testing may be used
to determine homogeneity of the blend. FDA is going to issue a new draft guidance
on blend uniformity.
The Blend Uniformity Working Group (WG) is urged by the SC to provide a work plan for its projects.
Conflict of Interest Issue
The Drug Product TC and Blend Uniformity WG requested the clarification
of whether members of TC or WG can participate in the performance of PQRI projects.
The SC felt that TCs and WGs were intentionally staffed with knowledgeable scientists
and there should not be any conflict of interest if members of the TCs and WGs
were to be in charge of or performing experiments with the projects.
Report on Other Working Groups
Steven Byrn, Ph.D., Chair, Drug Substance TC, reported the formation of
three working groups: Particle Size/Physical Properties WG, Drug Substance Specifications
WG and Impurities WG for SC to review. SC approved the Particle Size/Physical
Properties WG. The other two WGs need representatives from PhRMA for balance.
Steven Byrn had applied to the State of Indiana for possible funding of the above PQRI projects. If approved, the State of Indiana will match dollar to dollar any funding that PQRI can provide to these projects. SC applauded the action of Steven Byrn.
PQRI/CDER Memorandum of Understanding
Helen Winkle presented a draft of the Memorandum of Understanding between
FDA and PQRI. All member organizations are asked to review the document and
provide comments. The topic will be discussed at the next SC Meeting, December
7, 2000.
Counterfeit Drugs Proposal
Discussion of the Counterfeit Drugs Proposal will be postponed to next SC
meeting on December 7, 2000.
Education, Communication and Assessment Subcommittee
Ed Fry, chair of the subcommittee, will draft a proposal for conduction of workshops
or training sessions under the auspices of PQRI for the better collaboration
between member organizations.
Next Meeting
An SC meeting has been scheduled at the AAPS Headquarters, Arlington, VA
on December 7, 2000, 10:00 AM – 5:00 PM.