IPEC-‐PDG Working group
Compendial
Review/Harmonization
Hold technical meetings with PDG on as needed basis/meet yearly with PDG
On-‐going monograph harmonization
Meet with PDG late Oct to plan agenda for Nov meeting
JECFA/Food Related Issues related to Mg Stearate
Compendial
Review/Harmonization
To support EFSA (European Food Safety Authority) need for Mg stearate exposure data, where used, what products it's used in, etc., work with IPEC makers & users of Mg stearate to gather necessary Mg stearate information.
1) Dave S. to create and send summary of situation to IPEC membership
2) DK and PZ to work with staff to develop list of excipients linked to each IPEC member
Support Elemental Impurity Coalition
Compendial
Review/Harmonization
Support Trade Association coalition on the Rationale Implementation of Elemental Impurities
Rationale implementation of Global Elemental Impurity requirements for
pharmaceutical excipients
Coalition projects include -‐ 1) develop comments re:USP chapter by Mar 30
2) develop Q&As for FDA FAQ 3) develop real data on acid leach methodology
4) finalize PDE Calculator and develop instructions
5) summarize and share (USP/ICH) historical acid leach information USP Monograph
Modernization Project
Compendial
Review/Harmonization
Request IPEC member companies to send samples of the 13
excipients identified in the FDA letter to USP along with any methods still needed
Commitment from members to submit samples
Report from members on Sept 26; samples of guar gum sent by Ashland
Support publication of FDA 2012 EI study/data
Compendial
Review/Harmonization
Work with John Kauffman and Gang Li at FDA Research labs to
substantiate their work and publish an article in Pharmaceutical Science
Scientific article on Elemental Impurities in excipients published in peer reviewed journal
Review FDA data/interpretation of data and finalize draft report
Guidance on User Comminication with Suppliers (FOR THE PARKING LOT)
Excipient Qualification
A guide/stimuli article or addition to the EIP guide which would discuss the communication between users and
suppliers/makers. It would detail / describe which type of information should be shared between the two.
TBD
Some notes from the EQ meeting on Feb. 26th: It has been proposed to have better guidance on what users should communicate to their suppliers regarding their use of the excipient. It was agreed that users should share more “non-‐
confidential” information on how a material is used. This might be the basis for a new guide that would describe what type of information should be shared. This might be a perfect fit under the “excipient qualification” guide or, if too long and complex, it might be a supplement/reference in/to the guide.
Excipient Information
Package Excipient Qualification
Revise 2012 EIP guide and develop new version.
Revised EIP Guide published as Federation Guide.
1) Waiting for IPEC Europe (Helen Stubbs) to communicate with us to have first joint meeting
Quality Agreement
Guide Excipient Qualification
Revise 2009 Quality Agreement and develop new version
Revised and updated version of Quality Agreement Guide as Federation Guide.
1) Waiting for IPEC Europe (Johanna Eisele) to communicate with us to have first joint meeting
Significant Change
Guide Excipient Qualification
Revise and update the 2009 version of IPEC Significant Change Guide.
To publish 2014 IPEC Significant Change Guide (ideally as a Federation guide, and at the least a "bi-‐ PEC guide)
1) Publication of the final guide on IPEC-‐Americas and Europe websites 2) Paper copies if needed (EU is printing some) 3) Iain to give presentation at IPEC Europe in Feb. in Nice France. 4) ExcipientFest Americas in Puerto Rico
presentation to take place on April 28th
How to Creat a Bi-‐Pec
Guide Excipient Qualification
Develop a process on “best practices/lessons learned/policy” on how to create a “Bi-‐PEC” guide. Included will be a discussion around how to communicate that a
commenting period is over.
Protocol
Bretta/Heather to present 1st draft to Executive Committee at
December meeting
IPEC Global Risk Assessment Strategy (RAT -‐ Risk Assessment Team)
Excipient Qualification
To develop a risk assessment guide which would include 1) guidance on conducting manufacturer’s internal risk assessment for GMP (EXCiPACT, NSF/IPEC 363), and 2) risk
assessment from users perspective (IPEC Europe). The guide may also cover risk assessment for atypical actives, decision making for significant changes etc.
IPEC Americas will provide to IPEC Federation-‐ the following content for the risk assessment guidance document:
• Process including
methodologies and tool box for conducting risk
assessment
• How-‐to chapters on internal risk assessment from excipient
manufacturers perspective • How-‐to chapters on internal risk assessment from excipient users perspective
1) A draft Table of Contents for the Guide has been developed (Meera, Lisa, Bretta Dale) 2) Based on response to internal poll, experts have been identified to lead subteams focussing on a risk assessment methodology. 3) The charter has been amended and sent to the Federation
Excipient Qualification
Guide (PARKING LOT) Excipient Qualification
Revise and update the latest version of IPEC Excipient Qualification Guide
To publish an IPEC Excipient Qualification Guide (ideally as a Federation guide, and at the least a "bi-‐PEC guide)
TBD
Bi-‐PEC/IPEC Glossary of
Terms Executive Committee
review and update current 2010 IPEC-‐Americas Glossary and work with other PECs to make it global
IPEC Federation Glossary of Terms
get feedback from IPEC-‐Europe on draft glossary sent to them in 2013 ANSI cGMP for
Pharmaceutical Excipient Standard
Good Manufacturing Practice
Develop ANSI Pharmaceutical Excipient Standard
Approved ANSI
Pharmaceutical Excipient Standard
FDASIA Atypical Actives on-‐going activities
Good Manufacturing Practice
work with FDASIA subcommittee to be prepared for potential meeting with FDA
Tool chest of discussion items pertaining to atypical actives for requested FDA meeting
1) define the problems and propose a process parallel to the food / dietary supplements process that occurred within FDA
2) check NDC database for listings for common atypical actives 3) inform CHPA, GPhA, etc about IPEC activities and suggest coalition Revised IPEC-‐PQG
Excipient GMP Guide
Good Manufacturing Practice
Rewrite IPEC/PQG GMP Guide with updated information from ANSI Excipient GMP standard
Revised IPEC-‐PQG Excipient
GMP Guide draft revisions Validation Guide Good Manufacturing
Practice
Develop IPEC GUIDE on Excipient Validation, including Equipment, Process, Product, Computer, Cleaning and Analytical Validation
Published IPEC GUIDE on Excipient Validation
finalize Validation Guide section on computerization
Technically Unavoidable Particles Profile (TUPP) Guide
Good Manufacturing
Practice Develop IPEC TUPP GUIDE Published IPEC TUPP GUIDE
1) submit to IPEC office for final editing and to XC for final approval 2) review with FDA
Additives found in excipients
Quality by Design Product Development
Develop and share with FDA a list of additives commonly found in excipients
Share list of additives commonly found in excipients with FDA
Original list to be updated. Updated project proposal to be drafted
Co-‐processed Excipient Guide
Quality by Design Product Development
create a new IPEC Guide pertaining to co-‐processed excipients
Published IPEC Co-‐
processed Excipient Guide
Final edits to be made and then sent to XC for approval
QbD Excipients and Excipient Variability Guide
Quality by Design Product Development
Develop IPEC GUIDE on QbD Excipients and Excipient Variability
Published Federation IPEC GUIDE on QbD Excipients and Excipient Variability
1) Aim to have version to send to other PECs after Sept. meeting QbD Sample Guide Quality by Design
Product Development
Create and publish new QbD Sampling Guideline
Published IPEC QbD
Sampling Guide draft Guide Global Ingredient
Archival System (GinAS) Project
Regulatory Affairs
Help communicate and support the FDA/NIH/global regulatory GInAS innitiative
functional Global ingredient identification database with reviewed/reliable ingredient information
call-‐in to bi-‐weekly GInAS meetings, attend GInAS public workshop, Washington DC, June 10-‐11, 2014
Addressing US Import
issues Regulatory Affairs
Address current issues companies are currently experiencing when importing excipients into the US.
Response from FDA on Import hold letter. IPEC-‐ Americas would like the opportunity to connect with the appropriate resources at FDA in order to allow both parties to openly
communicate and collaborate on this topic.
None. Milestone achieved. Bretta Lichtenhan and Priscilla Zawislak attended meeting with FDA in Rockville in June of 2014. Visit report was created after the meeting. Meeting was able to resolve current issues. In addition, FDA was formally invited to come speak at IPEC in September, but they have not gotten back to us.
FDA IID update Regulatory Affairs Support FDA clean-‐up and update of US FDA IID
Improved FDA IID database and process for toxicology assessments for families of similar products
Meet with FDA IID Sub team to 1) discuss revisions to draft FDA toxicology table
2) agree on interim process for bridging family "safety" information 3) follow up on Phase 1 IID FAQ 4) begin review of Phase II IID FAQ
Revise IPEC Master File
Guide Regulatory Affairs
Update content/instructions and format/granularity. Target working with FDA to define their current and future needs (e.g. electronic filing, format/granularity, etc)
Revised IPEC Master File Guide. Work on draft prior to september meeting. Target date is end of 2014.
Meeting with FDA to discuss FDA current and emerging DMF requirements
FDA Portable Document Format (PDF)
Specifications
Regulatory Affairs
We need to clarify with the FDA on what PDF attachments to
regulatory filings (NDAs, INDs or ANDAs) are impacted by this guidance. Also, IPEC Americas will issue a position paper with inpu with FDA.
IPEC position paper
clarifying FDA's requirement and applicabiltiy to excipient documents
Acid Leach/PQRI
workshop; Safety
Propose a project/program to PQRI for a multi day/multi functional (tox, analytical, USP, FDA, mfg., etc) workshop to promote an EI
workshop focused on methods and the analytical/toxicological impact of acid leach vs. total digestion
scheduled multi day/multi functional workshop
work with PQRI to finalize workshop plans
XC approval and agreement to fund from 2014 budget
Steinberg Award for
Foundation Safety
develop a branding/marketing plan for the award
sustainable plan for delivering the Marshall Steinberg Award
identify new definition and criteria for the award to recognize not only toxicologist but all involved in the evaluation, qualification,
assessment and promotion of novel and existing excipients for safety Chris DeMerlis/Elaine Knight agreed to rediscuss the award at SOT with Shawn at the upcoming SOT meeting.
Form a Novel Excipient
sub-‐committee projects Safety
Define members to work in an IPEC-‐ Americas Novel Excipient
subcommittee, formalize team and develop mission
Sub-‐committee and projects identified, mission / charter developed
meet with team identified in Q1 to develop a mission statement and to determine how to move forward
IQ Initiative; Safety
IPEC-‐Americas/IQ Consortium subteam to prepare for a meeting with the FDA to discuss a new pathway for novel excipients in June 2014
open ended, TBD
Prepare a backgrounder document to send to the FDA providing history and legislative reasons why a new, novel excipient pathway is critical Small subteam (Nigel Langley/Chris DeMerlis from IPEC and Keith Horpol/? Will participate in a round table inteview by PharmTech during ExcipientFest on the subject of Novel Excipients.
Stimuli article on novel excipient solutions for drug delivery
Safety
Develop and publish stimuli article on benefits of using NOVEL EXCIPIENTS in drug applications
Stimuli Article on Novel Excipients
Develop/publish IPEC-‐Americas “concept paper” (stimuli article?) on solutions for how novel
excipients might be used to resolve current drug delivery issues. Nano technology/nano-‐
materials subteam Safety
define a working group/chair person to monitor for
regulatory/toxicology issues related to nano materials. It was
recommended that the team might focus on such things as analytical
Sub-‐team identified and a mission statement
developed
1) survey IPEC-‐Americas members for those interested to participate in nano-‐technology team; 2) work with the sub-‐team members to develop a mission statement. * for questions on any
committee or committee activity, please contact IPEC-‐ Americas office
