IPEC- Americas Ongoing Projects

Transcription

1 Hold technical meetings with PDG IPEC- PDG Working On- going monograph Meet with PDG late Oct to plan on as needed basis/meet yearly group harmonization agenda for Nov meeting with PDG JECFA/Food Related Issues related to Mg Stearate Support Elemental Impurity Coalition USP Monograph Modernization Project Support publication of FDA 2012 EI study/data To support EFSA (European Food 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 chapter by Mar 30 Rationale implementation of 2) develop Q&As for FDA FAQ Support Trade Association coalition Global Elemental Impurity on the Rationale Implementation of Elemental Impurities Request IPEC member companies to send samples of the 13 excipients identified in the FDA letter to USP along with any methods still needed Work with John Kauffman and Gang Li at FDA Research labs to substantiate their work and publish an article in Pharmaceutical Science requirements for pharmaceutical excipients Coalition projects include - 1) develop comments re:usp 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 Report from members on Sept 26; Commitment from members samples of guar gum sent by to submit samples Ashland Scientific article on Elemental Impurities in excipients published in peer reviewed journal Review FDA data/interpretation of data and finalize draft report

2 Guidance on User Comminication with Suppliers (FOR THE PARKING LOT) 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 Quality Agreement Significant Change Revise 2012 EIP guide and develop new version. Revised EIP published as Federation. Revised and updated Revise 2009 Quality Agreement and version of Quality develop new version Agreement as Federation. Revise and update the 2009 version of IPEC Significant Change. To publish 2014 IPEC Significant Change (ideally as a Federation guide, and at the least a "bi- PEC guide) 1) Waiting for IPEC Europe (Helen Stubbs) to communicate with us to have first joint meeting 1) Waiting for IPEC Europe (Johanna Eisele) to communicate with us to have first joint meeting 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

3 How to Creat a Bi- Pec IPEC- Americas Ongoing Projects Develop a process on best practices/lessons learned/policy on how to create a Bi- PEC guide. IPEC Global Risk Assessment Strategy (RAT - Risk Assessment Team) Protocol Included will be a discussion around how to communicate that a commenting period is over. IPEC Americas will provide to IPEC Federation- the following content for the risk assessment guidance document: To develop a risk assessment guide which would include 1) guidance on Process including conducting manufacturer s internal methodologies and tool box risk assessment for GMP (EXCiPACT, for conducting risk NSF/IPEC 363), and 2) risk assessment assessment from users perspective How- to chapters on (IPEC Europe). The guide may also internal risk assessment cover risk assessment for atypical from excipient actives, decision making for manufacturers perspective significant changes etc. How- to chapters on internal risk assessment from excipient users perspective Bretta/Heather to present 1st draft to Executive Committee at December meeting 1) A draft Table of Contents for the 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 (PARKING LOT) Bi- PEC/IPEC Glossary of Terms ANSI cgmp for Pharmaceutical Excipient Standard Executive Committee Revise and update the latest version of IPEC Excipient Qualification review and update current 2010 IPEC- Americas Glossary and work with other PECs to make it global Develop ANSI Pharmaceutical Excipient Standard To publish an IPEC Excipient Qualification (ideally as a Federation guide, and at the least a "bi- PEC guide) IPEC Federation Glossary of Terms Approved ANSI Pharmaceutical Excipient Standard TBD get feedback from IPEC- Europe on draft glossary sent to them in 2013 resolve outstanding FDA concerns

4 FDASIA Atypical Actives on- going activities Revised IPEC- PQG Excipient GMP Validation Technically Unavoidable Particles Profile (TUPP) Additives found in excipients Co- processed Excipient QbD Excipients and Excipient Variability QbD Sample Global Ingredient Archival System (GinAS) Project work with FDASIA subcommittee to be prepared for potential meeting with FDA Rewrite IPEC/PQG GMP with updated information from ANSI Excipient GMP standard Develop IPEC GUIDE on Excipient Validation, including Equipment, Process, Product, Computer, Cleaning and Analytical Validation Develop IPEC TUPP GUIDE Tool chest of discussion items pertaining to atypical actives for requested FDA meeting Revised IPEC- PQG Excipient GMP Published IPEC GUIDE on Excipient Validation Published IPEC TUPP GUIDE Develop and share with FDA a list of Share list of additives additives commonly found in commonly found in excipients excipients with FDA create a new IPEC pertaining to co- processed excipients Develop IPEC GUIDE on QbD Excipients and Excipient Variability Create and publish new QbD Sampling line Help communicate and support the FDA/NIH/global regulatory GInAS innitiative Published IPEC Co- processed Excipient Published Federation IPEC GUIDE on QbD Excipients and Excipient Variability Published IPEC QbD Sampling functional Global ingredient identification database with reviewed/reliable ingredient information 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 draft revisions finalize Validation section on computerization 1) submit to IPEC office for final editing and to XC for final approval 2) review with FDA Original list to be updated. Updated project proposal to be drafted Final edits to be made and then sent to XC for approval 1) Aim to have version to send to other PECs after Sept. meeting draft call- in to bi- weekly GInAS meetings, attend GInAS public workshop, Washington DC, June 10-11, 2014

5 Addressing US Import issues FDA IID update Address current issues companies are currently experiencing when importing excipients into the US. Support FDA clean- up and update of US FDA IID None. Milestone achieved. Bretta Response from FDA on Lichtenhan and Priscilla Zawislak Import hold letter. IPEC- attended meeting with FDA in Americas would like the Rockville in June of Visit opportunity to connect with report was created after the the appropriate resources at meeting. Meeting was able to FDA in order to allow both resolve current issues. In addition, parties to openly FDA was formally invited to come communicate and speak at IPEC in September, but collaborate on this topic. they have not gotten back to us. 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 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. Work on draft prior to september meeting. Target date is end of Meeting with FDA to discuss FDA current and emerging DMF requirements FDA Portable Document Format (PDF) Specifications 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

6 Acid Leach/PQRI workshop; Propose a project/program to PQRI for a multi day/multi functional (tox, analytical, USP, FDA, mfg., etc) scheduled multi day/multi workshop to promote an EI functional workshop workshop focused on methods and the analytical/toxicological impact of acid leach vs. total digestion work with PQRI to finalize workshop plans XC approval and agreement to fund from 2014 budget Steinberg Award for Foundation Form a Novel Excipient sub- committee projects IQ Initiative; develop a branding/marketing plan for the award Define members to work in an IPEC- Americas Novel Excipient subcommittee, formalize team and develop mission IPEC- Americas/IQ Consortium subteam to prepare for a meeting with the FDA to discuss a new pathway for novel excipients in June 2014 sustainable plan for delivering the Marshall Steinberg Award Sub- committee and projects identified, mission / charter developed open ended, TBD 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. meet with team identified in Q1 to develop a mission statement and to determine how to move forward 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.

7 Develop/publish IPEC- Americas Stimuli article on novel Develop and publish stimuli article concept paper (stimuli article?) Stimuli Article on Novel excipient solutions for on benefits of using NOVEL on solutions for how novel Excipients drug delivery EXCIPIENTS in drug applications excipients might be used to resolve current drug delivery issues. Nano technology/nano- materials subteam * for questions on any committee or committee activity, please contact IPEC- Americas office 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.