Tag Archive: Regulatory Compliance

Annex 21 – Are we on track and is there an impact?

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…

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…

Bridging the Gap: Role Clarity, Skill Investment, and the Battle Against Drug Shortages 

December 20, 2023 || Chris Spiak
As advancements in medical science continue to expand the array of available treatments, the demand for pharmaceuticals has surged.  This surge has caused an alarming increase in drug shortages.  Complex factors, including regulatory hurdles, supply chain disruptions, and unforeseen global events, have converged to create a landscape where the availability…

Challenges Implementing a Dark Factory in Biotechnology Manufacturing

December 11, 2023 || David Shenberger
The concept of a “dark factory” conjures images of secrecy and clandestine operations, but in the world of biotechnology manufacturing, it represents an innovative approach to production that promises increased efficiency, quality, and safety. A dark factory is an automated facility that minimizes human intervention, and the operations are primarily…

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…

Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

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…

Solving Drug Shortages With AI

November 10, 2023 || Nick Armstrong
Explore the positive impact of artificial intelligence (AI) on pharmaceutical manufacturing, addressing persistent drug shortages. Dive into the benefits of predictive analytics, quality control enhancements, and supply chain optimization. However, as we unlock the potential of AI, we acknowledge and tackle concerns like data quality, fairness, and regulatory compliance for responsible implementation. Join us in revolutionizing drug manufacturing and ensuring reliable access to essential medications through the transformative power of AI.