Summary Minutes of the Manufacturing Technical Committee

Summary Minutes of the Manufacturing Technical Committee

Thursday, July 10, 2014

8:30 AM – 10:00 AM ET

Teleconference Information:

1-866-570-1041

Switzerland: 0800562835

Passcode: 544861

Welcome/roll call done by Chair.

Antitrust Statement read by Chair.

Minutes approval – Comment made to amend the minutes to reflect that the Process Validation Workshop could coincide with the 2015 FDA Conference. Change made during the telecom.

Review of actions from June meeting– Discussed as part of the Reports from Work Groups.

Reports from Working Groups:

• Excipient Variability – Chairspoke of the survey during the USP Expert Committee and Stakeholder meetings and the idea was well received. Action Item:Chair needs to work to format the survey for Survey Monkey and begin the distribution process.
• Compounding vs Manufacturing “Where is the Line” – Chair advised of the

Interim Guidance on Outsourcing facilities and where we can add value; Action Item:Chair to put together a small group of experts to review the guidance and create comments for the MTC to review and submit on behalf of PQRI. MTC Chair volunteered to be a member of this group to review the Guidance.

• Elemental Impurities workshop in collaboration with IPEC-

Target conference Spring 2015; IPEC rep is constructing the planning committee and will have a telecom in the very near future; Action Item: they will create a draft agenda to submit it to the SC for approval and then a budget can be created and we can seek a venue. FDA Conference on Evolving Quality – registration is open and marketing efforts are underway; Action Item: will seek to have FDA place the conference info on the landing page for the FDA similar to what was done for the Nano Workshop to show its prominence; EU rep will assist with the marketing efforts in the EU and make phone calls on our behalf to promote the conference.

• Proposal for MTC Project on Process Validation –discussed the presentation to the SC and their approval of the concept and the recommendation that the MTC consider hosting this workshop as a stand-alone and/or integrating it into the Annual FDA Conference in 2015. Action Item: will work on a draft agenda for a stand-alone meeting on this topic to get MTC approval prior to submitting it back to the SC; will seek input from the Compliance folks at FDA prior to the Aug. MTC meeting.

Date for face to face MTC on September 16 or 17- members selected to try to have a MTC meeting on the morning of Sept. 17th at 7:30 am prior to the start of the conference on that date. Action Item:PQRI will contact the hotel to see if we can get space and then let the MTC know the details.

2014 Meeting Schedule – all are TCs at 8:30 - 10:00 AM

o 09 January

o 13 February

o 13 March

o 10 April

o 08 May

o 12 June

o 10 July

o 14 August

o 11 September (possible face to face during FDA Quality workshop on September 17th)

o 09 October

o 13 November

o 11 December