International Pharmaceutical Excipients Council Of the Americas
Arlington, Virginia (2-May-2016)
IPEC-Americas Publishes Quality by Design Sampling Guide for Excipient Makers, Users, and
Since the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) announced in 2011 their intention to evaluate the use of Quality by Design (QbD) principles in the development of pharmaceutical formulations for new drug applications1, pharmaceutical formulators have increasingly adopted QbD principles. With its adoption, however, there is a need for closer collaboration between drug makers and excipient makers in the provision of samples representing realistic variability in excipient composition and other critical material attributes (CMAs). Such samples will enable drug makers to develop more practical and robust manufacturing processes and gain an enhanced understanding of CMAs which have the potential to impact drug product quality.
With this in mind, IPEC-Americas has published its Quality by Design Sampling Guide, a free resource intended to:
- Recommend options for the provision of appropriate Quality by Design (QbD) samples to allow excipient variability to be incorporated into the Design of Experiments (DoE(s)) for drug product development.
- Assist drug makers in developing more robust processes and products in the context of the excipient manufacturer’s process capability.
- Facilitate communication between drug makers and excipient suppliers with regard to realistic provision of samples before planning and executing a DoE.
- Delineate user and excipient supplier roles and responsibilities.
The Guide is available for download at no charge to IPEC-Americas members and non-members (after registering) by visiting the IPEC Store. IPEC-Americas is also offering an informative free webinar on the QbD Sampling Guide June 15th (2:00PM-4:00PM EDT) for Makers and Users - READ MORE.
IPEC is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with its counterparts in Europe, China, Japan, and India serves as a primary international resource on excipients for its members, governments, and public audiences.
For additional information and technical inquiries, contact Linda Herzog at 201-994-9117