21
Nov

FDA Inspections Summit: Emerging from Covid and the Future of Data Integrity

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 […]

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09
Nov

CDER Advisory Committee Votes to Progress Quality Management Maturity

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 […]

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28
Sep
Quality Agreements Image

Great Quality and Great Business Is Interdependence in Plain Sight?

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 […]

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09
Sep

Annex 1: A Step Increase in Sterile Manufacturing Requirements

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 […]

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30
Aug

“GMP By the Sea” Reflections

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 […]

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14
Jun
Young man looks at road map near on mountain road, Switzerland

To Measure or Not to Measure, Quality Metrics Is the Question!

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 […]

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