Committees

IPEC-Americas Standing Committees, Subcommittees & Technical Working Groups

CRC-Compendial Review

CRC-Compendial Review

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

Next Meeting Date:
not scheduled
Location:

IPEC-Americas Office, Arlington, VA - WebEx

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Douglas G. Muse
Sr. Principal Associate – Compendial Affairs
Eli Lilly and Company
Vice Chair: Jennifer Putnam
R&D Supervisor II
Perrigo

EQ-Excipient Qualification

EQ-Excipient Qualification

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
Next Meeting Date:
not scheduled
Location:

IPEC-Americas Office, Arlington, VA - WebEx

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Ann Gulau
Quality Manager, Nutrition & Biosciences-Pharma Solutions
IFF
Vice Chair: Candy Reynolds-Cummings
Quality Assurance and Regulatory Manager, Smart Materials & Speciality Additives
Evonik

GMP - Good Manufacturing Practice

GMP - Good Manufacturing Practice

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

 

Next Meeting Date:
not scheduled
Location:

IPEC-Americas Office, Arlington, VA - WebEx

Contact to Join Meeting:

ipecamer@ipecamericas.org

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

QbD-Quality by Design

QbD-Quality by Design

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
Next Meeting Date:
not scheduled
Location:

IPEC-Americas Office, Arlington, VA - WebEx

Contact to Join Meeting:

ipecamer@ipecamericas.org

Vice Chair: Stacey Bremer
Director, Product Stewardship
Celanese
Chair: David R. Schoneker, MS
Consultant
Black Diamond Regulatory Consulting
Working Group(s):
Excipient Composition

RA-Regulatory Affairs

RA-Regulatory Affairs

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.

Next Meeting Date:
not scheduled
Location:

IPEC-Americas Office, Arlington, VA - WebEx

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Meera Raghuram
Manager, Global Regulatory Strategy and Policy, Personal, Home and Health Care
Lubrizol Advanced Materials, Inc.
Vice Chair: Troy Barrix
Principal Regulatory Compliance Specialist
Celanese

Scientific Affairs Committee

Scientific Affairs Committee

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

Next Meeting Date:
not scheduled
Location:

IPEC-Americas Office, Arlington, VA - WebEx

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Lisa W. Webber
Director – SQM/Procurement Process Deployment
Johnson & Johnson
Vice Chair: Charlotte McIlvaine
Manager - North America Pharma Quality
Univar Solutions USA Inc.

Excipient Learning Lab (ELL)

Excipient Learning Lab (ELL)

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.

Next Meeting Date:
not scheduled
Location:

IPEC-Americas Headquarters

Contact to Join Meeting:

ipecamer@ipecamericas.org

: Irwin B. Silverstein, Ph.D.
Lead Trainer and Consultant

Users Network

Users Network

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.
Next Meeting Date:
Monday, December 11, 2023 - 2:00pm to 3:00pm
Location:

Virtual - WebEx

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Heather Sturtevant
Vice Chair for User Relations
IPEC-Americas

IPEC-Americas  2023 Committee Meetings will take place at IPEC-Americas headquarters: 3138 10th Street N. Arlington, VA 22201

Local area hotels

The Executive Committee meets on Tuesday's 8:00 am - 1:30 pm during Committee week

Working Groups

  • (ELL) Excipient Learning Lab
  • Users Network
  • Makers/Distributors Network

Volunteers needed! 
IPEC-Americas offers leadership opportunities - if you want to get more involved, please click here to share your interest:  https://www.surveymonkey.com/r/WLX682H

Quick Links:

IPEC-Americas Organization Chart

Committee Projects

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