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 HQ - Arlington, VA

Contact to Join Meeting:

ipecamer@ipecamericas.org

Phyllis Walsh
Chair: Phyllis Walsh
Associate Director
Merck & Company, Inc
George Collins
Vice Chair: George Collins
Vice President
Vanderbilt Mineral Co.

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 HQ - Arlington, VA

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Ann Gulau
Quality Manager
The Dow Chemical Company
Heather Sturtevant
Vice Chair: Heather Sturtevant
Manager, Technical Operations
McNeil Consumer Healthcare (J&J)

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 HQ - Arlington, VA

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Paul Smutz
Global Compliance Manager
Henkel Corporation
Vice 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 HQ - Arlington, VA

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Joseph Zeleznik
Manager of Technical & Regulatory Affairs
MEGGLE USA, Inc.
Vice Chair: David R. Schoneker, MS
Director of Global Regulatory Affairs
Colorcon
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 HQ - Arlington, VA

Contact to Join Meeting:

ipecamer@ipecamericas.org

Meera Raghuram
Chair: Meera Raghuram
Manager, Global Regulatory Strategy and Policy, Personal, Home and Health Care
Lubrizol Advanced Materials, Inc.
Katherine L. Ulman
Vice Chair: Katherine L. Ulman
KLU Consulting

Safety Committee

Safety 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 HQ - Arlington, VA

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: Lisa W. Webber
Director – SQM/Procurement Process Deployment
Johnson & Johnson
Vice Chair: Charlotte McIlvaine
Area Quality Manager
Univar 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:

Sept. 12: Telecon only / Dec. 6: IPEC-Americas HQ - Arlington, VA

Contact to Join Meeting:

valeria.stewart@ipecamericas.org

: Linda Herzog
Training, Technical & Membership Operations Specialist
IPEC-Americas
: Irwin B. Silverstein
Lead Trainer and Consultant
IPEC-Americas

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:
not scheduled
Location:

IPEC-Americas HQ - Arlington, VA

Contact to Join Meeting:

ipecamer@ipecamericas.org

Chair: David B. Klug, MS
Vice Chair for User Relations
IPEC-Americas

The Executive Committee meets on Thursdays from 1-5pm during Committee week

Working Groups

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

Volunteers needed! 
There is currently a Vice Chair vacancy for the Safety committee. If you are a member and have an interest in volunteering to assist, please contact our office at (571) 814-3449. Vice chair responsibilities include taking meeting minutes at meetings or telecons.

Quick Links:

IPEC-Americas Organization Chart

Committee Projects

Contact our office if you plan to attend or want to be added to a committee distribution list.