Exceeding Your Benchmark – Benchmark Products
Pharmaceutical manufacturers are under increasing pressure to deliver sterile, high-quality medicines in smaller batches and faster cycles. As pharma manufacturing evolves, regulatory demands have intensified, especially following the 2023 revision of EU GMP Annex I, which places new emphasis on contamination control strategies, improved traceability, and minimizing human intervention throughout production. According to American…
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Benchmark Products
Sterile Compounding and Contamination Control with Abby Roth
In this episode of Exceeding Your Benchmark, host Michelle Dawn Mooney speaks with Abby Roth, founder of Pure Microbiology, about sterile compounding and contamination control. Abby shares her expertise in microbiology, sterile environments, and best practices in pharmaceutical compounding. The conversation begins with a distinction between traditional drug manufacturing and sterile compounding, highlighting the…
Benchmark Products
One Year of The Exceeding Your Benchmark Podcast
Benchmark Products provides products for critical life science and pharma environments. In this podcast series Exceeding Your Benchmark, they interview leading experts on a variety of trending topics. In celebration of its first year, Exceeding Your Benchmark looks back at interviews with experts from life science and pharmaceutical manufacturing on timely topics from Annex…
Exceeding Your Benchmark - Benchmark Products
Exploring the Fundamentals of Validation in Life Science Manufacturing
In the rapidly evolving domain of life science manufacturing, validation emerges as a cornerstone to ensure that products meet stipulated requirements concerning quality, safety, and efficacy. This pivotal aspect of manufacturing comes to focus as regulatory landscapes shift, mandating stringent compliance to ensure patient safety. In a recent episode of Exceeding Your Benchmark, a…
Articles Healthcare
Pharmaceutical Manufacturing is Witnessing Major Transformation as New Demands for Sterility Assurance Reshape Healthcare
For an industry where precision and quality control are paramount, pharmaceutical manufacturing is witnessing an evolutionary leap in contamination control practices. Propelled by changes in regulatory environments, such as the EU’s Annex 1 update and ICH Q9 focusing on quality risk management, the sector is shifting from isolated, data-point-centric strategies towards a more holistic…
Exceeding Your Benchmark - Benchmark Products
Connecting Data to Improve Your Contamination Control Strategies
Contamination control is absolutely critical in the pharmaceutical industry and includes particulate, microbial, product carryover, chemical, and viral aspects of contamination and often involves proactive, reactive, and supporting aspects. However, regulations, liabilities, and patient health added to the mix create data silos that often form multiple processes and make it difficult to create efficient and…
Exceeding Your Benchmark - Benchmark Products
Revolutionizing the Audit Process: Advancements in Supplier Assessments Within the Pharmaceutical Sector
Pharmaceutical companies invest significant resources in research and development to discover new drugs and therapies and improve existing ones. This involves rigorous testing, clinical trials, and obtaining regulatory approval before a drug can be sold. Government agencies, such as the Food and Drug Administration (FDA) in the United States, oversee the approval process and conduct…
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Navigating the Denial Pipeline: How Medicare Advantage Plans Reshape Access to Care
Medicare Advantage was sold as a smarter, more efficient way to care for seniors, but too often the efficiency seems to land on the wrong side of the patient–provider relationship. When plans deny or delay needed services through opaque rules and weak oversight, beneficiaries feel it first—in missed therapies, postponed procedures, and a…
Rebecca Interview: When Peer-to-Peer Reviews Stop Being About the Patient
Behind the sterile labels of “inpatient” versus “observation” care is a messy reality: clinicians and insurers often enter peer-to-peer reviews without a shared rulebook, turning what should be a clinical dialogue into a box-checking exercise. The speaker’s frustration points to a broader problem in U.S. healthcare utilization management—decisions about coverage can feel pre-decided,…
Navigating Payer Denials: A Physician Advisor’s Perspective #2
A physician advisor recently described a case that should unsettle anyone who cares about fair, clinically grounded coverage decisions: a Medicaid patient arrived comatose from an overdose, was emergently intubated, developed aspiration pneumonia, and stayed through three midnights before leaving against medical advice. By any bedside standard, this is acute, unstable care—exactly what…
Navigating Payer Denials: A Physician Advisor’s Perspective #1
America’s healthcare system is buckling under a contradiction we’ve normalized: we expect reliable care for roughly 380 million people while letting every major lever of the system be pulled by for-profit players chasing the same dollar. In any market, companies will optimize for profit, but in medicine that instinct collides with a rulebook…
