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IPEC-Americas and IPEC Europe Publish Risk Assessment Guide for Excipient Makers, Users, and Distributors

Tuesday, May 30, 2017

Arlington, Virginia (30-May-2017)

PRESS RELEASE (download)

IPEC-Americas and IPEC Europe Publish Risk Assessment Guide for Excipient Makers, Users, and Distributors.

The Guide is available for download at no charge to IPEC-Americas members and non-members (after registering or logging in with existing account) by visiting the Document Depot (under Resources - IPEC Guides). 

Use of risk based decision making to ensure that attention is focused on critical areas of product quality is not new to the pharmaceutical industry.  Risk assessment is a driving principle of quality standards for excipients including the NSF/IPEC/ANSI 363[1] and EXCiPACT™ [2] excipient GMP standards.  Various regulations globally require use of risk assessment in determination of appropriate manufacturing controls to ensure excipient quality.  The diversity of excipient manufacture, type of material and application means that a “one size fits all” approach to excipients does not provide the necessary assurances of product quality and patient safety. With this in mind, IPEC-Americas and IPEC Europe have published the Risk Assessment Guide, a free resource intended to provide a systematic and scientifically sound methodology for the evaluation of risk to excipient quality and to facilitate more effective and consistent risk-based decisions by excipient makers, distributors, and users.

The IPEC Risk Assessment Guide - Part 1 is designed to provide excipient suppliers with an overview of risk assessment tools, and resources that they can use, when conducting risk assessments to identify and control for potential risks to excipient quality.  The overview includes:

  • quality risk management;
  • the scientific principles of risk identification and assessment; and,
  • an outline of the process and use of appropriate risk assessment methodologies.

Additional sections to the risk assessment guide are planned for the future.

IPEC’s unique combination of experts from excipient makers, distributors and users makes this association uniquely positioned to understand the underlying risks to excipient quality. IPEC’s mission is to ensure that excipients meet the highest appropriate standards for quality, safety and functionality throughout their manufacturing process and supply chain. The use of risk management principles applied to excipients furthers this cause.