Committee: Compendial Review Committee
Chair: Priscilla Zawislak

2011 Accomplishments:

• Harmonized ethylcellulose monograph issued, USP established expert panel on     povidones - IPEC companies represented on panel, provided input to PDG on propylene glycol assay specs, providing support as needed for USP's monograph modernization project; providing support for USP/FDA initiatives on EMA

• Joint effort on propylene glycol assay, cellulose derivative viscosity, povidones, glycerin

• Elemental impurities waiting for ICH input, residual solvents - EO to be removed from USP <467> in 2012, viscosity of cellulose derivatives - no consensus from working group on best approach to harmonization, workshop to be planned for early 2012 to get more input from industry, TiO2 being moved to bilateral harmonization; talc expert panel set up by USP, expert panel on glycerin still being set up by USP

• Bilateral harmonization request sent to USP & EP, awaiting decision (TiO2, MHEC, Type 12 CMC)

• EC propyl gallate being added to monograph, other additives/processing aids information being gathered for review with FDA

• Monitor at each meeting, IPEC provided comments to FDA re: proposed guideline

2012 Goals:

• Hold elemental impurities workshop 1st half 2012 to discuss ICH Q3D proposal and obtain industry input on limits, test methods, etc.

• Obtain industry input for approach for measurement of viscosity of cellulose derivatives

• Achieve harmonization of excipient monographs and general chapters published by USP/NF, EP and JP.

• Work with counterpart committees from regional IPEC Federation members and IPEC-Pharmaceutical Discussion Group (PDG) in harmonization process

• Significant monographs & chapters for 2012 include: elemental impurities, viscosity of cellulose derivatives, cellulose derivatives, povidones

• Work with USP & EP to implement bi-lateral harmonization on specific monographs

• Continue to support addition of additives/processing aids in specific monographs

• Monitor nanotechnology and microbiological developments with respect to impact on monographs

Committee: Excipient Qualification
Chair: Juanita Garofalo

2011 Accomplishments:

• Revised CoA Guide with IPEC Europe – incorporating FDA comments

• Subcommittee has completed update Excipient Information Package

2012 Goals:

• Revision of Significant Change Guide with IPEC Europe

• Assist FDA’s Effort to develop Spectral Library for screening of Pharmaceutical Excipients

Committee: Good Manufacturing Practices
Chair: Ann Van Meter

2011 Accomplishments:

• Validation Guide almost complete

• Reviewed ANSI NSF 363 standard and EXCiPACT standards

• Risk Assessment Guide started

• Parking lot items collected for revising IPEC PQG GMP to align with ANSI and EXCiPACT

2012 Goals:

Committee: Quality by Design - Product Development
Chair: Brian A.C. Carlin, Ph.D.

2011 Accomplishments:

• Conducted a QbD workshop with 100 FDA reviewers and CDER compliance personnel on December 5 at FDA White Oak office

• Conduct member update webinars to share the information presented to the FDA

• Additives list compiled for meeting with FDA

• Excipient Composition guide-Response to EMA

• Visible particles in Solid excipients guideline under development – meet with FDA to review when draft is completed

2012 Goals:

• Continue to participate in PQRI working group studying excipient critically to successfully manage risks associated with excipient related product quality variation

Committee: Regulatory Affairs
Chair: Teresa Chan, Co-Chair: Katherine L. Ulman

2011 accomplishments:

• Created a global database of acceptable international excipients and drug products with applicable links and resources

• Developed examples of excipient DMFs for China SFDA. Reviewed and provided feedback to SFDA (through IPEC China) on the second draft of the China SFDA Master File (DMF) for excipients (December 2011)

• Began developing an understanding for timing and requirements for electronic DMF filing

• Developed an extensive backgrounder document and met with personnel from FDA OGD on December 9th to discuss unintended consequences of recent, unannounced, changes to the FDA IID. Began to develop an action plan for resolving issues

• Japan Earthquake/Nuclear plant advisement paper: Posted on website

2012 Goals:

• Complete revision of IPEC-Americas Excipient Master File Guide

• Continue to network with FDA OGD to resolve unintended consequences and clean up the FDA Inactive Ingredient Database
• Work with FDA to review changes currently underway with their DMF Guidance

• Develop a summary compilation of existing international excipient Phthalate issue position paper on website

Committee: Safety Committee
Chair: Chris DeMerlis

2011 Accomplishments:

• A paper was accepted for publication in the International Journal of Toxicology for 2012

• A paper was sent to Dale Carter and the IPEC Executive Committee for review which was then sent by Dale to the IPEC federation. The paper will be sent to the ICH EWG after review by the Federation

• The IPEC Procedure was promoted at the ExcipientFest exhibit and to the attendees. The Procedure was also promoted at the CRS meeting in August.

• An article was published in Tablets & Capsules about the new Excipient Evaluation Procedure. Also a presentation was given at the Eastern Analytical Symposium in November in New Jersey.

• We now have 6 members of the committee and Brian serving as co-chair.

2012 Goals: