Read, Learn, Innovate: Top Blog Posts from November 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Meet Sanofi – 2020 Facility of the Year Award Winner for Facility of the Future
Sanofi is the 2020 Facility of the Year Award Winner for Facility of the Future for their Sanofi Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, Massachusetts.
Meet Eli Lilly and Company – 2020 Facility of the Year Award Winner for Operational Excellence
Eli Lilly and Company is the 2020 FOYA Category Winner for Operational Excellence for their Lilly Innovation Development Center in Indianapolis, Indiana.
What is the Impact of Article 117 on the Pharma Industry?
Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain aspects of the Medical Device Regulation apply to the device component of the product.
Design Review/Design Qualification
This blog is the last of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide provides a well-defined framework for a lifecycle quality risk management (QRM) commissioning and qualification (C&Q) approach to verification and documentation of fitness for use.
ISPE Responds to PIC/S: Additional GMP for ATMPs & Biologics Recommendations
This article summarizes the panel discussion on Learnings from COVID-19 and some related consideration by the ISPE moderators. The session explored how the industry and regulators are managing the challenges presented by COVID-19 and what can be learned for the future.
