Quality Risk Assessment for Excipients: An Industry Perspective
27. May 2015
By Patricia Van Arnum posted Tue, May 26, 2015 01:51 PM
The IPEC Federation has issued a position paper on European Union (EU) guidelines for excipients based on quality risk management. Although supporting risk assessment, the organization raised concerns over timing for a March 2016 deadline for risk assessments as incomplete assessments may jeopardize the availability of excipients. IPEC issued the position paper earlier this month to put forth several issues for consideration in the implementation of the risk management and good manufacturing practice (GMP) principles of the EU guidelines, including the necessary collaboration and cooperation along the entire supply chain to avoid gaps in a holistic risk-assessment process. A look at the key points raised…