31: EU GMP Chapter 1 Update: The quiet rewrite that may change QRM auditability.

In this episode, Lori and Val explore the proposed update to Chapter 1 of the EU GMPs - Eudralex Volume 4. The update solidifies formality in Quality Risk Management and is clear that it expects subjectivity to be minimized. Join us as we discuss what this means in reality and how moving these expectations from a guidance to an inspection standard might impact QRM implementation.

SHOW NOTES:
The proposed update to Chapter 1 of the EU GMPs
https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-1_en#respond-to-the-consultation
Article by Dr Emma Ranmarine on Drug Shortages
https://www.pda.org/pda-letter-portal/home/full-article/drug-shortage-is-a-wicked-problem
Article by Dr Marty Lipa on connecting QRM and KM:
https://prst.ie/wp-content/uploads/2020/11/Knowledge-as-the-Currency-of-Managing-Risk-Uniting-QRM-and-KM-28Oct20-FINAL-for-Level3.pdf