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 || LeAnna Pearson
Introduction: In a global community, studies are often conducted by testing facilities located outside of the United States of America, including countries such as Brazil, China, India, and Japan. The final test reports and accompanying documentation require translation from the facility’s native language to English when performing the testing. All…
April 3, 2024 || Cheryl Bondurant
When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I asked the question why should we focus on regulatory inspection remediation instead of prevention of inspection remediation? For those of you who have been involved…
March 18, 2024 || Connie Leech
Most people take for granted that medication prescriptions will be ready at the pharmacy counter and available for pick up when ordered to get themselves on the road to recovery. The COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. While some aspects…
March 18, 2024 || Connie Leech
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical products, thereby enhancing patient outcomes and overall satisfaction. Manufacturers can consistently deliver sterile medications and devices by employing state-of-the-art aseptic processing techniques, reducing the risk…
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On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).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…
January 15, 2024 || Martina McDonagh
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 patients. These shortages can be for a variety of factors including manufacturing and quality issues. To this end the FDA embarked on the Quality Management…
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 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 20, 2023 || Rosario Hughes-Kielty
To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality Risk Management (QRM) principles have emerged as a key strategy in achieving this goal. QRM details a comprehensive evaluation of risks associated with both patient…
