Committees

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

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

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

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

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.

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

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.

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.