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…
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…
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.
