IPEC-‐Americas Ongoing Projects PUBLIC FORUM Possible Federation Description Project Project name Committees IPEC-‐PDG Working group Compendial Review/Harmonization Hold technical meetings with PDG On-‐going monograph on as needed basis/meet yearly harmonization with PDG 13-‐Sep-‐13 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. 13-‐Sep-‐13 Compendial Review/Harmonization Rationale implementation of Support Trade Association coalition Global Elemental Impurity on the Rationale Implementation of requirements for Elemental Impurities pharmaceutical excipients 13-‐Sep-‐13 USP Monograph Modernization Compendial Project 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 13-‐Sep-‐13 Support publication of FDA 2012 Compendial EI study/data Review/Harmonization Scientific article on Elemental Work with John Kauffman and Gang Impurities in excipients Li at FDA Research labs to published in peer reviewed substantiate their work and publish journal an article in Pharmaceutical Science JECFA/Food Related Issues related to Mg Stearate Support Elemental Impurity Coalition Final deliverable Last UpdatedDATE Commitment from members to submit samples 24-‐Jan-‐14 IPEC-‐Americas Ongoing Projects Project name Committees Possible Federation Description Project Final deliverable Last UpdatedDATE A guide/stimuli article or addition to the EIP guide which would discuss the communication between users and TBD suppliers/makers. It would detail / describe which type of information should be shared between the two. 4-‐Mar-‐14 Guidance on User Comminication with Suppliers (FOR THE PARKING LOT) Excipient Qualification Excipient Information Package Excipient Qualification Yes Revise 2012 EIP guide and develop Revised EIP Guide published as new version. Federation Guide. 30-‐Sep-‐14 Quality Agreement Guide Excipient Qualification Yes Revised and updated version of Revise 2009 Quality Agreement and Quality Agreement Guide as develop new version Federation Guide. 30-‐Sep-‐14 Yes To publish 2014 IPEC Significant Revise and update the 2009 version Change Guide (ideally as a 30-‐Sep-‐14 of IPEC Significant Change Guide. Federation guide, and at the least a "bi-‐PEC guide) Yes Develop a process on “best practices/lessons learned/policy” on how to create a “Bi-‐PEC” guide. Protocol Included will be a discussion around how to communicate that a commenting period is over. Significant Change Guide How to Creat a Bi-‐Pec Guide Excipient Qualification Excipient Qualification 30-‐Sep-‐14 IPEC-‐Americas Ongoing Projects Project name Committees IPEC Global Risk Assessment Strategy (RAT -‐ Risk Assessment Excipient Qualification Team) Possible Federation Description Project Yes Final deliverable IPEC Americas will provide to IPEC Federation-‐ the following content for the risk assessment To develop a risk assessment guide guidance document: which would include 1) guidance on conducting manufacturer’s internal • Process including risk assessment for GMP (EXCiPACT, methodologies and tool box for NSF/IPEC 363), and 2) risk conducting risk assessment assessment from users perspective • How-‐to chapters on internal (IPEC Europe). The guide may also risk assessment from excipient cover risk assessment for atypical manufacturers perspective actives, decision making for • How-‐to chapters on internal significant changes etc. risk assessment from excipient users perspective Last UpdatedDATE 22-‐Oct-‐14 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 5-‐Mar-‐14 ANSI cGMP for Pharmaceutical Excipient Standard Good Manufacturing Practice Develop ANSI Pharmaceutical Excipient Standard Approved ANSI Pharmaceutical Excipient Standard 13-‐Sep-‐13 FDASIA Atypical Actives on-‐ going activities Good Manufacturing Practice work with FDASIA subcommittee to Tool chest of discussion items be prepared for potential meeting pertaining to atypical actives with FDA for requested FDA meeting 13-‐Sep-‐13 IPEC-‐Americas Ongoing Projects Project name Committees Revised IPEC-‐PQG Excipient GMP Good Manufacturing Guide Practice Possible Federation Description Project Rewrite IPEC/PQG GMP Guide with updated information from ANSI Excipient GMP standard Develop IPEC GUIDE on Excipient Validation, including Equipment, Process, Product, Computer, Cleaning and Analytical Validation Final deliverable Last UpdatedDATE Revised IPEC-‐PQG Excipient GMP Guide 13-‐Sep-‐13 Published IPEC GUIDE on Excipient Validation 13-‐Sep-‐13 Published IPEC TUPP GUIDE 18-‐Sep-‐13 Validation Guide Good Manufacturing Practice Technically Unavoidable Particles Profile (TUPP) Guide Good Manufacturing Practice Develop IPEC TUPP GUIDE Additives found in excipients Quality by Design Product Development Develop and share with FDA a list of Share list of additives additives commonly found in commonly found in excipients excipients with FDA Co-‐processed Excipient Guide Quality by Design Product Development QbD Excipients and Excipient Variability Guide Quality by Design Product Development QbD Sample Guide Quality by Design Product Development Global Ingredient Archival System (GinAS) Project Regulatory Affairs Addressing US Import issues Regulatory Affairs create a new IPEC Guide pertaining Published IPEC Co-‐processed to co-‐processed excipients Excipient Guide Published Federation IPEC Develop IPEC GUIDE on QbD GUIDE on QbD Excipients and Excipients and Excipient Variability Excipient Variability Create and publish new QbD Published IPEC QbD Sampling Sampling Guideline Guide functional Global ingredient Help communicate and support the identification database with FDA/NIH/global regulatory GInAS reviewed/reliable ingredient innitiative information Response from FDA on Import hold letter. IPEC-‐Americas would like the opportunity to Address current issues companies connect with the appropriate are currently experiencing when resources at FDA in order to importing excipients into the US. allow both parties to openly communicate and collaborate on this topic. 22-‐Oct-‐14 22-‐Oct-‐14 25-‐Feb-‐14 22-‐Oct-‐14 3-‐Mar-‐14 28-‐May-‐14 IPEC-‐Americas Ongoing Projects Project name FDA IID update Revise IPEC Master File Guide Committees Possible Federation Description Project Final deliverable Last UpdatedDATE Regulatory Affairs Improved FDA IID database and Support FDA clean-‐up and update process for toxicology 28-‐May-‐14 of US FDA IID assessments for families of similar products Regulatory Affairs Update content/instructions and Revised IPEC Master File Guide. format/granularity. Target working Work on draft prior to with FDA to define their current 28-‐May-‐14 september meeting. Target and future needs (e.g. electronic date is end of 2014. filing, format/granularity, etc) FDA Portable Document Format Regulatory Affairs (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. 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 27-‐Feb-‐14 develop a branding/marketing plan sustainable plan for delivering for the award the Marshall Steinberg Award 27-‐Feb-‐14 Safety Steinberg Award for Foundation Safety IPEC position paper clarifying FDA's requirement and applicabiltiy to excipient documents 28-‐May-‐14 IPEC-‐Americas Ongoing Projects Project name Committees Possible Federation Description Project Final deliverable Last UpdatedDATE Safety Define members to work in an IPEC-‐ Sub-‐committee and projects Americas Novel Excipient identified, mission / charter subcommittee, formalize team and developed develop mission 28-‐Feb-‐14 Safety IPEC-‐Americas/IQ Consortium subteam to prepare for a meeting with the FDA to discuss a new open ended, TBD pathway for novel excipients in June 2014 28-‐Feb-‐14 Stimuli article on novel excipient Safety solutions for drug delivery Develop and publish stimuli article Stimuli Article on Novel on benefits of using NOVEL Excipients EXCIPIENTS in drug applications 28-‐Feb-‐14 Nano technology/nano-‐materials Safety LIBRARY 1) IPEC Americas team identified to monitor for nano-‐ technology/nano-‐material Collect current and emerging information. publications, presentation, etc on 2) IPEC-‐Americas library nano-‐technology/nano-‐materials, established to store Oct. 23, 2014 develop reference list and library of information (documents, documents. presentations, etc) on nano-‐ technology/nano-‐materials. 3) list of referenced materials developed Form a Novel Excipient sub-‐ committee projects IQ Initiative; IPEC-‐Americas Ongoing Projects Project name Committees Possible Federation Description Project Final deliverable Nano technology/nano-‐materials Safety subteam define a working group/chair person to monitor for regulatory/toxicology issues related to nano materials. It was Sub-‐team identified and a recommended that the team might mission statement developed focus on such things as analytical methods, sample preparations and particle characterization Excipient Qualification Guide (PARKING LOT) Revise and update the latest version of IPEC Excipient Qualification Guide * for questions on any committee or committee activity, please contact IPEC-‐Americas office Excipient Qualification Yes To publish an IPEC Excipient Qualification Guide (ideally as a Federation guide, and at the least a "bi-‐PEC guide) Last UpdatedDATE 3-‐Mar-‐14 30-‐Sep-‐14
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