All Committees

IPEC-Americas places great value in its active member volunteers - they are the leaders and drivers of our organization.

Here's how you can become a more active member:
Join a committee, working group and/or serve as an ambassador at quarterly meetings.

Contact our office if you would like more information.

Compendial Review (CRC)

Chair: Douglas Muse, Sr. Principal Associate, Compendial Affairs, Eli Lilly and Company
Vice Chair: Jennifer Putnam, Senior Supervisor AR&D, Perrigo

Responsible for harmonization of excipient monographs between the United States Pharmacopeia, the European Pharmacopeia and the Japan Pharmacopeia. The Harmonization Committee may work in conjunction with other regional Pharmaceutical Excipients Councils to achieve this goal. The Committee shall consult with the Chair on matters related to the IPEC Federation. Technical working groups may communicate directly with their regional Excipient Council equivalents.

The Compendial Review/Harmonization Committee reviews the following Compendial Monographs/General Chapters:
> CMC Sodium
> Carboxymethylcellulose/Carmellose
> Crospovidone
> Ethylcellulose
> Gelatin
> Glycerine/Sorbitol Solutions/Propylene Glycol
> Heavy Metals
> Hydroxyethylcellulose
> Hydroxypropylcellulose
> Methyl Cellulose
> Polyethylene Glycol
> Propylene Glycol
> Residual Solvents
> Silicone Dioxide
> Starches
> Titanium Dioxide

Excipient Qualification (EQ)

Chair: Candy Reynolds-Cummings, Quality Assurance and Regulatory Manager, Evonik
Vice Chair: Kayla Thompson Allen, Regulatory Professional, Food, Nutrition & Pharmaceuticals, Ashland

Provides guidance to excipient manufacturers on the development of an excipient grade material and its specifications; guidance on how users select and assess excipients for use in their formulations; and guidance on elements included in the necessary excipient maker-user negotiating process leading to quality requirement agreements between the parties.

Guides developed by the Excipient Qualification Committee include:
> (EIP) Excipient Information Protocol
> (CoA) Certificate of Analysis
> Significant Change
> Quality Agreement
> Risk Assessment

Good Manufacturing Practice (GMP)

Chair: Mike Cassell, cGMP Quality Assurance Manager, Eastman Chemical Company
Vice Chair: Beth Febbo, Global Laboratory & Project Manager, Henkel Corporation

Responsible for developing and maintaining good manufacturing practices and related guidelines, including:
> Excipient GMP Guide
> Excipient GMP Audit Guide
> Stability Guide
> GDP Guide
> Validation Guide
> Atpical Actives

Latin America Working Group

Lead: Fernando Mucelin, Sr. Manager, Life Science, Regulatory Manager - Americas, Ashland

The group's mission will be to advocate, educate, innovate and develop best practices for pharmaceutical excipients in the region, prioritizing patient safety and drug product efficacy. It will be focused on manufacturers, importers and distributors of pharmaceutical excipients as well as finished drug manufacturers in Latin America. In addition, this group will be able to share and leverage guidance on international guidelines of good practices for pharmaceutical excipients, promote training opportunities and advocacy actions with local authorities and government agencies aimed at harmonizing and adopting international practices for pharmaceutical excipients in the region.

Quality by Design (QbD)

Chair: David Schoneker, Consultant, Black Diamond Regulatory Consulting
Vice Chair: Stacey Bremer, Director, Product Stewardship, Celanese

Composed of pharmaceutical formulators, new product and excipient development scientists and other experts from industry and academia to assist in the establishment of standardized decision-tree processes for developing experimental study plans to better understand the link between excipient properties and functions in different formulations and manufacturing systems. The Quality by Design Product Development Committee also coordinates the development of any guidelines which may assist in product development or formulation of new excipient or drug products.

Guides developed by the QbD committee include:
> Excipient Composition
> Quality by Design
> QbD Sampling
> Excipient Variability

Regulatory Affairs (RA)

Chair: Bob Sulouff, Regulatory Affairs Advocacy Manager, IFF
Vice Chair: Troy Barrix, Principal Regulatory Compliance Specialist, Celanese

Responsible for assessing excipient related regulations and regulatory guidelines that are promulgated by FDA or international regulatory agencies and coordinating the development of IPEC positions on these issues. The Regulatory Affairs Committee also develops IPEC Americas guidelines to support excipient use and development in the United States with consideration to international drug registration processes and monitors associated regulations in the food additive arena which may have implications on the use of pharmaceutical and dietary supplement excipients.

Scientific Affairs Committee (SAC)

Co-Chair: Alexa Smith, Director, Global Quality & Regulatory Services, Colorcon
Co-Chair: Teresa Wegesser, Principal Scientist, Amgen

Responsible for providing safety guidance requested by the Board of Trustees, the Executive Committee, or by any Standing Committee.

The Excipient Learning Lab (ELL)

Lead: Kathy Ulman, Consultant, KLU Consulting

The Excipient Learning Lab is the IPEC-Americas working group that manages training and educational programs offered to members and non-members, with a focus on excipients.

Users Network

Lead: Heather Sturtevant, Manager, Technical Operations, Kenvue, formerly McNeil Consumer Health (J&J)

The Users Network is a working group formed to:
> Discuss inputs such as from member companies, pharmaceutical industry trade organizations, emerging trends and regulations that affect users.
> When appropriate, propose initiatives and projects to the IPEC-Americas executive committee for possible action by its committees and/or the IPEC Federation.
> Interface and advocate on behalf of IPEC with pharmaceutical industry trade organizations.
> Discuss pain points and work collaboratively to develop and share best practice as it relates to excipients.

Makers/Distributors Network

Description coming soon!