Do you know if your QC laboratory weighing practices are defensible? They may not be if weighing controls are treated as routine rather than as a critical part of the analytical process. Because weighing underpins many test procedures and methods, unreliable balance data can compromise results throughout an assay. Earlier this year (February 2026), the […]
I read two articles today that made me wonder what the next year will look like for enforcement activity in the compounding arena. First was an article by Peter Pitts published in RealClear Health (here) titled “The Compounding Loophole Has Become a Business Model”. The second is a report in the Pink Sheet written by […]
Today on FDA’s website, Elizabeth Miller, PharmD, Associate Commissioner for Inspections and Investigations, and Lowell Zeta, JD, Acting Chief of Staff and Deputy Commissioner for Strategic Initiatives, penned an article (here) titled Investing in FDA’s Inspectional Enterprise. The article outlined FDA’s view of the evolving nature of the FDA inspections program and outlined several objectives […]
Artificial intelligence is transforming virtually every industry, from healthcare and pharmaceuticals to finance and national security. Yet as adoption accelerates, so does evidence of harm. The Organization for Economic Co-operation and Development (OECD) AI Incidents Monitor (AIM), which tracks publicly reported AI incidents and hazards worldwide now contains more than 16,000 documented incidents and hazards, […]
Have you assessed the strategic risk of your company’s readiness to meet the following regulation in the future? “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions (21 CFR 211.25(a))” Or […]
In the pharmaceutical industry, some of the most important regulatory expectations are not always found in the main body of a guidance document. Occasionally, a seemingly modest footnote carries significant implications for the future of compliance. One such example appears in the MHRA GxP Data Integrity Guidance and Definitions (March 2018), which states: “It is […]
Pharmaceutical companies are under constant pressure to reduce operating costs without compromising product quality. There are a number of factors that affect operating costs, and energy prices are one of many. Global fuel and energy prices remain volatile due to geopolitical issues. The U.S. Energy Information Administration reported that global oil markets remain in a […]
FDA issued a proposed rule titled “Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments” to modernize drug manufacturer listing requirements for certain entities. The proposed rule would permit a hub-and-spoke model single listing to identify multiple manufacturing sites engaged in a distributed manufacturing model. Now do […]
The pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]
In a previous blog posted on April 16, 2026 (here), we discussed the announcement from FDA regarding an upcoming meeting of the Pharmacy Compounding Advisory Committee to be held on July 23-24, 2026, focused on the inclusion of some active ingredients on the permitted pharmacy compounding list. That post identified seven peptide active ingredients that […]
