May 2, 2013 (PDF) - PQRI

Next Meeting-recommends we consider working on. MTC Chair will vet this letter through theMTC for their input as well. Item not accomplished at this time. MTC Chair willwork with FDA rep to draft letter.oAction Item: PQRIwill send out email as a reminder with directions to office andcall in information. Item accomplished.Work Group Reports-IR/MR SUPAC-• Chair received FDA portions of the paper and along with other comments will fold thoseinto the paper and have it ready for review in the next few months; paper should be readyfor publication in late summer; WG Chair attended at presented at Interphex. ActionItem: He will provide link to news article; look into possibility of workshop on how toimplement this guidance; may publish in Pharm Tech; consider a case study for theLifecycle/Quality workshop.Lifecycle Management/Quality Workshop-• FDA rep inserted comments he received on the agenda; there should be 6 BreakoutSession totals; transitions in FDA make assignment of FDA speakers and planningcommittee members difficult at this time. Action Item: PQRI will help set upteleconference for those people who volunteered to be on the pre-planning committee listto try to get the ball rolling on this workshop. Teleconference was set for Friday, May17 th at 10:30 am.Compounding Work Group-• Spokesperson at FDA spearheading their efforts. PQRI should go through her to find aniche for PQRI in this arena. Action Items: FDA rep will draft letter for MTC Chair tosend and MTC will ask USP rep for a person at USP to help champion this group.Excipient Variability –• Work plan is in revision with comments from the last MTC meeting. It should be ready togo to the SC for their consideration during the June 11 th meeting. Action Items: WGChair will do final updates to work plan and then send it to MTC Chair; He will work onskill set so that matrix can be used to recruit volunteers for the project; PQRI will createflyer for advertisement of the work group at the upcoming USP Stakeholders Forum on

June 7 th . PQRI will contact Catherine Sheehan at USP to get her support for the flyerdistribution at the USP meeting.IVIVC paper from workshop-• Corresponding Author is working with authors to pull together a paper on the resultsfrom the workshop. Member at Dissolution Technologies is amenable to using her articleon the workshop as a skeleton for the paper.PQRI Website update –• Site updates: the org chart is now linked to information regarding each block on the chart(SC, Board, TC, WG) and there is a brief summary of each area and then a list ofmembers for that group; publications page is being updated by each Technical Committeewith their respective publications• Publications- the MTC reviewed the site during the meeting as was able to makedecisions on each publication. Member will be asked to look at the article of “Results ofSurvey…” to advise if it is still relevant; MTC offered modifications to the web page forthe articles and those modifications were handled by IT on Friday, May 3 rd .Ideas for new WGs–• Combination Products- Action Item: MTC members to see if there are issues in thistopic area that could/should be addressed; identify those issues and what role PQRI canplay in resolving the issues and report same to the next MTC meeting.There being no further business to discuss, the meeting was adjourned at 1:55 pm. Nextteleconference is set for June 13, 2013 at 8:00 am – 10:00 am.