Tag Archive: EU GMP

The Future of FDA Regulatory Inspections:   

December 27, 2023 || Connie Leech
 
The Office of Regulatory Affairs (ORA) at the U.S. Food and Drug Administration (FDA) is currently buzzing with activity and exciting developments. Here’s a snapshot of what happened in the last 24 months:  In June 2023, the FDA updated its new model for the Office of Regulatory Affairs (ORA). This…

Reflecting Again on GMP Requirements for Marketing Authorization Holder

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…

State of Validation

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…

Compliance: Framing Success Utilizing PIC/S and EU GMP

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…