Exceeding Your Benchmark – Benchmark Products

Pharma Manufacturing: Meeting Annex I with Precision Machining for Safer Sterile Drug Production

precision machining

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…

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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…

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Exceeding Your Benchmark - Benchmark Products
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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…

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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…

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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…

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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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Mobile gaming has quietly become the largest segment of the global gaming industry, generating about $92 billion annually—more than both PC and console games. Yet for decades, many brands and agencies underestimated its reach, focusing instead on arena-filling esports tournaments or blockbuster console titles. With nearly everyone carrying a smartphone, however, mobile has become…

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Revenue Cycle
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Hospitals are juggling shrinking margins and rising costs while denial volumes remain stubbornly high. In the revenue cycle alone, hundreds of billions are lost annually to preventable errors and inefficiencies—in fact, Access Healthcare CEO Shaji Ravi cites more than $250 billion wasted each year. Meanwhile, payers have accelerated their use of AI to adjudicate…

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In June, Forbes profiled Billie Whitehouse, CEO and Creative Director of Wearable X, as she broke her silence about leading through a devastating health crisis. Diagnosed with stage 4 colon cancer at 27 while 22 weeks pregnant, Whitehouse underwent emergency surgery that ensured her survival, but came with the profound heartbreak of losing her…

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Critical care in the United States faces a mounting crisis. With a shortage of board-certified intensivists and younger, less experienced nurses filling ICUs, hospitals often struggle to provide timely, gold-standard care. Studies show that hospitals with board-certified intensivists in their ICUs see a 30% reduction in patient mortality, yet thousands of facilities still lack…

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In this podcast episode of “Exceeding Your Benchmark,” host Gabrielle is joined by Ashley Harp, Lead Process Engineer at CRB. They discuss the challenges manufacturing facilities like Life Science Companies are facing as they adapt to new technologies and advancements in manufacturing, specifically in the area of combining highly potent active pharmaceutical ingredients (HPAPIs) and…

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Between 2022 and 2030, the cell and gene therapy sector is expected to experience a compound annual growth rate (CAGR) of 39.42 percent, BioSpace said of a recent Vision Research Report. This is quite a large anticipated growth; how will startups and current manufacturing companies work to meet this growing demand? On today’s episode of…

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Over the summer new GMP Annex 1 regulations were released by the FDA and EMA, prompting new changes to become standard protocolin sterile manufacturing companies. By August 2023, the regulations will take effect and companies will have to ensure that they are in compliance with the guidelines set. Discussing this on a new podcast, host…

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