A Peer-Reviewed Journal Focused on GMPs and Validation
MAY 2025

Featured Article

FEATURED BOARD MEMBER
Rosalind Beasley
CEO
Main and Mission, Inc.
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Breaking Down Risk for Medical Device Hazard Analyses

Taylor Dieringer
Senior Staff Quality Engineer – Risk Management
iRhythm Technologies, Inc.

In medical device risk management, the structure of a hazard analysis greatly impacts both product development and post-market surveillance. A clear, intentional structure supports traceability, aligns with ISO 14971:2019, and enables effective risk control. This article explores three common structures for hazard analysis and highlights a flexible, practical option that aligns well with real-world data and regulatory expectations.

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Industry News
Regulatory Focus: Bach Uniformity and Drug Product Integrity (January 2025)
This guidance, when finalized, will describe considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. It also discusses how manufacturers can incorporate process models into commercial manufacturing control strategies.
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This Month's Dose of Knowledge

GMP for the Soul: Wellness Tips for Pharma Professionals

Taking care of your GMP responsibilities is all about precision—but don’t forget to take care of yourself too! Here are some quick tips to keep your professional and personal well-being in balance:
Mind the Details, Mind Your Mind: Just like documentation, your mental notes need clarity—take short breaks to clear your head and recharge during long validation or audit sessions.
Stay Hydrated, Stay Focused: Water is your best compliance buddy. Keep a reusable water bottle at your workstation to maintain focus and energy.
Build Your Compliance Tribe: Lean on your colleagues for support and knowledge sharing. Teamwork makes strict adherence easier and less stressful.
Engage in In-Depth Learning and Networking: Attend focused training conferences where you can dive deep into niche GMP topics, exchange insights, and grow your professional network with peers who share your commitment to excellence.
Celebrate Small Wins: Whether it’s a successful validation or a smooth audit, take a moment to acknowledge your achievements. It fuels motivation and morale.
Remember, strong products start with strong people. Here’s to your health and success—inside the cleanroom and beyond!
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We have spent the past three decades on an epic ride through the life science industry. With early beginnings in the FDA and globally-regulated environment, we understand the importance of exchanging knowledge to make drugs and devices safer, and equipment and processes more scientifically sound. In the end, exchanging knowledge not only improves lives, but also saves them.
Whether you attend one of our interactive conferences or webinars, or take advantage of our valuable free process documents; our goal is to provide tools and techniques that will have an instant impact on your core responsibilities.

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