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…
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 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…
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.
