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…

Read More

Latest

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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More

Latest

personal branding
Personal Branding Now Drives B2B Success, Customer Trust, and Competitive Advantage
December 5, 2025

Personal branding has rapidly shifted from a “nice-to-have” to a strategic imperative in B2B marketing, reshaping how companies communicate, differentiate, and build trust. As industries evolve and professionals take on more dynamic, multi-stream careers, visibility and authenticity have become critical assets. Key findings from the Edelman + LinkedIn Thought Leadership Impact Report show that…

Read More
IT
Real-World IT Practices Are Streamlining AV Deployments and Raising the Bar for Consistency
December 4, 2025

For years, the AV industry has discussed the long-anticipated convergence with IT—but that shift is no longer theoretical. With cloud adoption accelerating, hybrid work normalizing, and organizations rebuilding digital infrastructure after years of rapid change, AV systems now sit squarely on the IT backbone. In fact, the majority of newly upgraded conference rooms require network-centric…

Read More
ROI
ROI Case Study
December 3, 2025

Denials are no longer a slow leak in the revenue cycle—they’re a fast-moving, rule-shifting game controlled by payers, and hospitals that don’t model denial patterns in real time end up budgeting around losses they could have prevented. PayerWatch’s four-digit, client-verified ROI in 2024 shows what happens when a hospital stops reacting claim by…

Read More
coverage
Clip 2 – Fighting for Coverage: One Patient’s Story
December 3, 2025

Health insurers love to advertise themselves as guardians of care, but the real story often begins when a patient’s life no longer fits neatly into a spreadsheet. In oncology especially, “coverage” isn’t a bureaucratic checkbox—it’s the fragile bridge between a treatment that finally works and a relapse that can undo years of grit…

Read More
Other Exceeding Your Benchmark - Benchmark Products
How Life Science Manufacturing Facilities Can Successfully Adapt To Change
February 11, 2023

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…

Read More
How Cell and Gene Manufacturers Can Scale to Meet Demand
December 21, 2022

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…

Read More
What Updated Annex 1 Regulations Mean for Sterile Manufacturing Companies in 2023
November 2, 2022

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…

Read More