EU Guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use were introduced in March 2015 at the same time as updates to EudraLex Volume 4, Part 1, Chapter 3 and 5. This guideline was introduced to provide a method for the assessment of the risks associated with excipients used in medicinal products, the establishment of the appropriate level of GMP control based on this risk and assessment of excipient suppliers risk profile against the chosen controls.
The excipient risk assessment methodology sits outside the supplier management program but provides a valuable connection between the requirements of an excipient in a product formulation and the ability of a supplier to provide an excipient with the desired characteristics. This webinar will discuss the key points in the performance of a compliant excipient risk assessment and how the PharmaLex tool, SMARTRISK, can help provide a solution for Marketing Authorization Holders that need support with the management of Excipient risk.
Director/Senior Consultant, Quality and Compliance, PharmaLex
Kate is a Quality professional with 18 years experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, High Potency oncology and Solid Oral Dose products. Kate is an SME in Quality Risk Management and works with her clients to deliver and remediate QRM programs providing efficiency and clarity across the product lifecycle.
The key learnings include:
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