Calling All Nitrosamine Risk-Assessment Practitioners! Help Us Pressure-Test USP’s New Practical Tool
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As I posted a few months back, over the past year our USP Nitrosamine team has been quietly building an Excel-based Risk Assessment Tool designed to walk users—step by step—through a structured investigation of nitrosamine risk across drug substances, excipients, and finished products. Its aim is simple: turn “What should I look at?” into “Here’s exactly how you can look at it.”
Now it’s time to find out how it performs outside our virtual four walls—and that’s where you come in.
Why we’re crowdsourcing
- Real-world practicality beats perfect theory. Even the best in-house prototype needs to survive the controlled chaos of everyday manufacturing and regulatory reviews.
- Collective expertise accelerates improvement. Many of you have written, reviewed, or received nitrosamine risk assessments and know where tools stumble—or shine.
- From “what” to “how.” Our community’s hallmark is translating guidance into executable practice; this exercise is the next step on that journey.
What we’re asking from volunteers
- Use the tool on a non-confidential case (or a mocked-up scenario) and note where it helps, where it hinders, and where it’s silent.
- Flag missing data fields, confusing logic, or clunky report outputs.
- Suggest additions or tweaks that would make adoption inside your organization easier.
- Share anonymized examples or summaries illustrating strengths, weaknesses, or unexpected edge cases.
Important: This is not a compendial ballot, revision request, or standard-setting process. It’s a peer-to-peer exchange—just like every other collaborative thread in Nitrosamines Exchange. Confidential IP, proprietary formulations, or patient data should not be uploaded.
How to participate
- Step 1 – Attend the kickoff briefing. In the coming weeks we’ll host a live, members-only session where the development team will demo the tool and explain the crowdsourcing plan.
- Step 2 – Opt in & accept the contributor terms. After the briefing, simply raise your hand (comment/DM) and agree to our participation guidelines—no confidential data will be shared or solicited.
- Step 3 – Get workspace access. Confirmed volunteers will receive a link to a private “virtual room” inside Nitrosamines Exchange, along with the tool, background deck, and discussion threads.
- Step 4 – Test, discuss, iterate. Use the tool on a non-confidential case, then post findings, questions, and suggestions directly in the workspace. USP team members will be active participants in every thread.
- Step 5 – Join regular follow-ups. We’ll schedule brief syncs (every 2-3 weeks) to track progress, clarify issues, and start consolidating the group’s collective input into actionable upgrades.
Let’s make this the most practical nitrosamine risk-assessment aid yet—together!
Our vision
A comprehensive, practical, and inclusive toolset that any nitrosamine team—large or small, innovator or generic—can deploy without specialized software or months of customization. Together we can raise the floor on risk-assessment quality and move the conversation from requirements to execution.
If you’re ready to help shape the next evolution of nitrosamine-risk best practice, drop a comment or send me a note. Help us build this—together.
Thank you in advance for sharing your expertise and keeping the Nitrosamines Exchange the most dynamic knowledge hub in our field. 