November 27, 2023 || Geraldine Carr-Mulry
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This paper, updated in January 2022, serves as an important guideline for MAH to understand their GMP responsibilities, especially in cases where they may not be…
November 27, 2023 || Jonathon Thompson, Director - Product Management
CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey. The survey targets current professionals in a validation, quality, or compliance function in industries governed by Data Integrity or ICH, FDA, and EU GMP Guidelines. This year’s survey results concluded that the…
November 21, 2023 || LeAnna Pearson
Introduction PIC/S was founded in 1995 as an extension of PIC (Pharmaceutical Inspection Convention). They are a non-binding cooperative arrangement between 56 different Regulatory Authorities. Just seeing the number 56 does not have the same impact as seeing the map below and understanding the true global reach of PIC/S. Their…
November 10, 2023 || Connie Leech and Geraldine Carr-Mulry
COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away, drug shortages have persisted on a global scale. The demand for flexibility in the supply chain remains imperative, However, many drug manufacturers are still reluctant…
