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
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…

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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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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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