July 18, 2024 || Cody Beaumont
Originally issued in 2005, ICH Q9 laid down principles and examples of tools for QRM that can be applied throughout the product lifecycle. It was a groundbreaking step towards integrating risk management into pharmaceutical quality systems, encouraging a proactive approach to potential risks, and fostering a culture of continuous improvement.…
April 26, 2024 || Geraldine Carr-Mulry
Annex 21 went into effect on August 21, 2022. It’s time to check that processes and procedures have not fallen short of the actual requirements specified in this guideline and to consider whether this guideline has helped manufacturers, healthcare providers, and patients. So, what is Annex 21? Annex 21 details the GMP…
February 9, 2024 || Emily Purchase
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has updated its guidance on remote regulatory assessments (RRAs), emphasizing that they differ from inspections and outlining new powers granted by a recent spending bill. The…
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…
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…
September 11, 2017 ||
What is an appropriate level of GMPs for a supplier manufacturing site?
