FDA Quality Management Maturity Program
Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the...
Read MoreThe Future of FDA Regulatory Inspections:
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...
Read MoreReflecting Again on GMP Requirements for Marketing Authorization Holder
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This...
Read MoreState of Validation
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...
Read MoreRevolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections
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,...
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