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

Featured Article

FEATURED SPEAKER GMP UNIVERSITY
Cindy Duhigg
Senior Principal, Global Manufacturing Science & Technology Engineering
Alcon Laboratories
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Data Pedigree – Getting to Know Your Data
Ronald D. Snee, PhD, Snee Associates, LLC

In the pharmaceutical world we talk a lot about Data Integrity. The FDA (2016) published A guidance for industry on matters involving data integrity. We hear analysts talking about Data Quality. Legal proceedings often question the “Chain of Custody of the Data.”​Metadata is also of concern when assessing Data Integrity (FDA 2016). I conjecture that these issues can be effectively discussed, understood, and assessed by using a common structure called “Data Pedigree,” the subject of this article.
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Industry News

Report on the State of Pharmaceutical Quality

The FDA has published the annual report on the State of Pharmaceutical Quality, characterizing the quality of the US drug supply chain. This report provides insights about import alert additions, recalls, and warning letter.
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This Month's Dose of Knowledge

This Fall’s Formula: Stay Focused, Stay Stress-Free

As summer winds down and we transition into the busy fall season, many of us face the challenge of juggling work, school, and personal responsibilities all at once. This shift can feel overwhelming, especially in the fast-paced world of life sciences. To help you navigate this period smoothly and reduce stress, here are five practical tips to prepare for a productive and balanced fall.
Plan and Prioritize Tasks: Create a clear to-do list or schedule for work and personal commitments. Prioritize tasks based on deadlines and importance to avoid last-minute stress.
Set Realistic Goals: Break down big projects or goals into manageable steps and set achievable deadlines. This helps maintain focus and prevents overwhelm as workload increases.
Maintain Healthy Habits: Stick to a regular sleep schedule, eat balanced meals, and stay hydrated. Incorporate physical activity—like walking or stretching breaks—to boost energy and mood.
Establish Boundaries: Clearly define work vs. personal time, especially if working remotely or balancing caregiving. This helps minimize burnout by allowing time to recharge.
Practice Mindfulness and Relaxation Techniques: Use brief meditation, deep breathing exercises, or journaling to manage stress. Taking a few minutes daily can improve mental clarity and resilience.

Remember, preparing for the fall with intention can make all the difference in how you experience this vibrant season. By taking small steps to organize, prioritize, and care for yourself, you’ll be ready to tackle new challenges with confidence and energy. Here’s to a successful and fulfilling fall ahead!

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