<span class="archive__title-prefix>Posts Categorized:</span> Trends & Analysis

According to FDA, we are at a “critical moment” where new technologies and emerging fields are leading to “groundbreaking” discoveries and innovative approaches to developing and manufacturing new drugs—the so-called “emerging technologies.” 1 Realizing this was the case, the agency’s strategic plan from nearly 10 years ago included its facilitation of the adoption of emerging […]

What is risk-based thinking? Ernest Blanchard, who has over 20 years of experience conducting system audits in a variety of industries and three years of study dedicated to risk in a doctoral program, dove into answering this question during the Deploying Risk-Based Thinking within Management Systems webinar hosted by Redica in April. To watch the […]

Faced in the past with increased pressure to reduce costs, drug manufacturers embraced just-in-time (JIT) or lean manufacturing supply chain inventory systems. This resulted in companies buying smaller quantities of raw materials from suppliers and reducing the number of materials in inventory, leading to an increased return on investment (ROI) among other benefits. As the […]

On Wednesday, March 11, 2020, the World Health Organization declared the spread of the respiratory illnesses caused by the novel coronavirus a pandemic.The impact of COVID-19 is being felt at home, at work, and across the globe. Pharma and medical device firms are taking precautionary actions that impact day-to-day operations.FDA and other global regulatory agencies […]

Firms that thought it wasn’t necessary to monitor import alerts that may have been placed against their suppliers received another lesson from FDA in January that they are wrong.  This is not the first warning letter of this type—five other warning letters address the topic including ones issued in 2019 to: Greenbrier International Vipor Chemicals […]

Updated 12/23/2019 to include the latest EMA publication. The past year and a half has seen a flurry of enforcement and investigative activity in the US, Canada and Europe regarding the contamination of pharmaceuticals with potential carcinogens. The enforcement ranges from a report of GMP non-compliance issued by the competent authority of Italy based on […]

At the secondXavier Health AI Summit,Amgen Quality Data Sciences Executive Director Dan Weese and Director Mark DiMartino presented the strategy, approaches, and lessons learned from their implementation of AI tools in Amgen’s quality processes, with a specific focus on the natural language processing (NLP) project used to analyze and trend manufacturing non-conformance reports (NCs). In […]

System validation, including validation of software for its intended use, is essential to GMP compliance for both drug and biologics manufacturers because computer systems are used in all phases of manufacture and analysis. Current enforcement actions identify how firms fail to meet existing drug GMPs (i.e., predicate rules) when using electronic systems and electronic records. […]

Yesterday, Dr. Janet Woodcock, FDA Director of the Center for Drug Evaluation and Research, released a statement regarding the recent recalls of Angiotensin II Receptor Blockers (ARB).  The statement outlines the minimal risk to patients taking the medication from the exposure to potential carcinogens (N-Nitrosodiethylamine (NDEA)) contaminants in the active pharmaceutical ingredient (API) in the […]

The United States Food and Drug Administration released a statement regarding a recently approved gene therapy drug, Zolgensma, intended to treat children less than two years of age with spinal muscular atrophy.  It is a critical therapy meeting an unmet need. However, the FDA was informed that the manufacturer, AveXis Inc., a subsidiary of Novartis, […]