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

Featured Article 

FEATURED SPEAKER
Joanne Goldberg
Senior Principal Business Analyst
Medtronic
Read Bio

Managing Nitrosamine Risks Across the Product Lifecycle
Jason Brown*, Adare Pharma Solutions
and Kim Huynh-Ba, Pharmalytik, LLC
*Corresponding Author

Nitrosamine impurities have emerged as a significant challenge in the pharmaceutical industry due to their carcinogenic potential and unexpected presence in various drug products. Regulatory authorities including the FDA, EMA, and WHO have responded with strict requirements for identification, risk assessment, and control of these impurities. While guidance continues to evolve, implementation remains complex. Jason Brown and Kim Huynh-Ba present a practical, science-based approach to managing nitrosamine risks throughout the product lifecycle—grounded in ICH Q9 and Q10 principles. (1)

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Industry News
GUIDANCE DOCUMENT
Computer Software Assurance for Production
and Quality System Software
Guidance
for Industry and Food and Drug Administration Staff
FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. This guidance describes a risk-based approach to establish confidence in the automation used for production or quality systems, identify where additional rigor may be appropriate, and various methods and testing activities that may be applied to establish computer software assurance. FDA’s goal is to help manufacturers produce high quality medical devices while complying with the Quality System regulation, 21 CFR Part 820. This guidance supplements FDA's guidance, "General Principles of Software Validation" except this guidance supersedes Section 6 ("Validation of Automated Process Equipment and Quality System Software") of the “General Principles of Software Validation” guidance.
 
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This Month's Dose of Knowledge

Harvesting Balance: A Seasonal Self-Check and
Smart Automation for Wellness

As the vibrant hues of fall spread, nature reminds us of the beauty in change and renewal. Just like trees shed their leaves to prepare for a restful winter, this season invites us to reflect on what habits we can let go of—and what new practices we can grow—to cultivate better work-life balance.   
 
This fall, empower yourself with a seasonal self-check to refresh your mental wellbeing, paired with smart automation strategies to optimize your workflow. Together, these can help you “harvest” more restful, focused, and productive days.
 
Tips for Your Autumn Wellness Harvest
 
Shed What Drains You: Take a moment to identify unproductive habits or tasks—both professional and personal—that weigh you down. This might mean saying no to certain meetings, delegating routine validation checks, or cutting back on late-night emails. Letting go creates space for focus and energy.
 
Plant New Routines: Introduce one small wellness habit this season—a 5-minute mindful breathing break, a quick outdoor walk during lunch, or a digital detox after work hours. These simple shifts nurture mental clarity and resilience.
 
Automate the Routine, Focus on the Unique: Use automation tools where you can—whether it’s automating parts of your data validation, compliance checks, or reporting through AI-driven solutions. Freeing up this mental bandwidth lets you tackle complex problem-solving and creative tasks without burnout.
 
Set Smart Boundaries with Tech: Schedule “no screen” times or set up notifications that limit distractions during your deep work periods. Automate status updates for your team, so everyone stays informed without redundant messages interrupting your flow.
 
Reflect and Adjust Like the Changing Leaves: Regularly review your progress. What’s working? What needs tweaking? Just as nature adjusts to the season, flexible adaptation helps you maintain balance amid ongoing professional demands.
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