The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections. As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see […]
Is a mature pharmaceutical quality system really a competitive advantage? The industry held this as a belief, but progress in a tangible program was always elusive. On November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]
If our supply chain was weak prior to the pandemic, this global event accelerated its failure. These signals of weakness were laid bare during the pandemic and identified in publications such as the 2019 report “Drug Shortages: Root Causes and potential Solutions” (here). Prior to the Covid PHE, focus on shortages was placed much more […]
A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (europa.eu)). Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf (europa.eu)) was just released on 22 August 2022. This document is […]
In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD. A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]
“Leaders win through logistics. Vision, sure. Strategy, yes. But when you go to war, you need to have both toilet paper and bullets at the right place at the right time. In other words, you must win through superior logistics.” (Tom Peters – Rule #3: Leadership Is Confusing As Hell, Fast Company, March 2001), from […]
“At the end of a wrench, is a patient.” The tragic events that happened twelve years ago aboard the Deep Water Horizon (yes, the one that the movie was based on) reinforced a sacred rule – accountability cannot be outsourced. For those who are not aware, of the approximately 126 personnel on board, only 7 […]
The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion. People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation. Thus, quality metrics were held tightly close to the chest of business leaders. Deming identified this […]
