IPEC Excipient Regulatory Overview – The Impact of Composition and Excipient Variability on QbD and Drug Performance

David Schoneker, Colorcon, Pennsylvania, USA

Introduction to IPEC and how IPEC Guidelines have become the Global Excipient expectations in most regions
- What is IPEC?
- The Need for IPEC
- Total Excipient Control
- Existing IPEC Guidelines regarding Excipient Design, Safety, Excipient Mfg. Process Control and Distribution
Differences between Food Additives, Excipients and APIs
Diverse Sources
Manufacturing Realities
Differences in Appropriate GMPs
Major Components
Residual Solvents
Elemental Impurities
Genotoxic Impurities
Additives and Residual Processing Aids
Unknown Unknowns
Excipient Critical Material Attributes
Sampling Concepts for Design of Experiments
Use of the FDA’s Inactive Ingredient Database (IID) to determine a Precedence of Use
Current Status of the IID
New Concepts for Novel Excipient Safety Evaluation (Qualification)
Excipient Compositional Profile – IPEC Composition Guide
Impact of Excipient Variability of Physical and Chemical Properties on QbD, Drug Performance and Stability
Excipient Safety Evaluation


IPEC Excipient Regulatory Overview – The Impact of Composition and Excipient Variability on QbD and Drug Performance David Schoneker, Colorcon, Pennsylvania, USA Introduction to IPEC and how IPEC Guidelines have become the Global Excipient expectations in most regions What is IPEC? The Need for IPEC Total Excipient Control Existing IPEC Guidelines regarding Excipient Design, Safety, Excipient Mfg. Process Control and Distribution Differences between Food Additives, Excipients and APIs Diverse Sources Manufacturing Realities Differences in Appropriate GMPs Major Components Residual Solvents Elemental Impurities Genotoxic Impurities Additives and Residual Processing Aids Unknown Unknowns Excipient Critical Material Attributes Sampling Concepts for Design of Experiments Use of the FDA’s Inactive Ingredient Database (IID) to determine a Precedence of Use Current Status of the IID New Concepts for Novel Excipient Safety Evaluation (Qualification) Excipient Compositional Profile – IPEC Composition Guide Impact of Excipient Variability of Physical and Chemical Properties on QbD, Drug Performance and Stability Excipient Safety Evaluation

Organized & Produced by:	www.isranalytica.org.il POB 4043, Ness Ziona 70400, Israel Tel.: +972-8-9313070, Fax: +972-8-9313071 Site: www.bioforum.co.il, E-mail: bioforum@bioforum.co.il